Complications of distraction osteogenesis: Narrative review

Kende, Prajwalit; Sarda, Ashish Sunilkumar; Desai, Harsh; Landge, Jayant; Nimma, Vijayalaxmi; Varte, Varthangpuii

doi:10.1111/ors.12613

Cited by 3 publications

(3 citation statements)

References 32 publications

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“…4,18 Micro-motion and patient movement in general contributes to pin-loosening which can exacerbate the incidence of these complications. 4,5 Internal or buried devices may decrease chances of these complications. Although a second operation is required for removal of internal/buried devices, they are proven to have a mechanical advantage when compared to external distractors.…”

Section: Discussionmentioning

confidence: 99%

“…Intraoperative or postoperative failure of these devices does occur and may require revision surgery and device reinsertion. 3 -5…”

Section: Introductionmentioning

confidence: 99%

“…Intraoperative or postoperative failure of these devices does occur and may require revision surgery and device reinsertion. [3][4][5] Failure to address these complications may compromise a patient's airway and mandible in the acute phase and in the long term, leading to further challenges in achieving a successful reconstruction. A previous meta-analysis has identified a number of hardware/procedure related complications (incidence) including device backup (20.6%), pain on activation (24.2%), and damage to dental roots (21%).…”

Section: Introductionmentioning

confidence: 99%

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Complications of Pediatric Mandibular Distraction Osteogenesis Hardware: A 10-Year Retrospective Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Jinka

Coombs

Murthy

2022

FACE

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Background: The United States Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database provides access to device related adverse event reports. This database mandates national reporting of complications that lead to “death and serious injury” by manufacturers, importers, and device user facilities. This study used MAUDE to conduct post-market surveillance of pediatric mandibular distraction osteogenesis (MDO) hardware. Methods: A MAUDE database search with terms related to mandibular distraction was performed for report dates between October 1st, 2011, and October 1st, 2021. Duplicate reports, reports from literature reviews, and vague reports were removed. Manufacturers were contacted to establish which devices were pediatric-use-only. Adult-use and mixed-use devices were excluded. Each remaining report was manually reviewed/categorized to compile summative data. Results: Seventy pediatric-use-only device reports were identified. The damaged/non-functioning part of the device included the distractor itself (57.14% of reports), footplate(s) (37.14%), or screw(s) (5.71%). Intraoperative and postoperative complications made up 15.71% and 84.29% of reports, respectively. Twenty percent of complications occurred during the activation phase and 1.43% occurred during device removal. The most common report was failure of the device to advance (37.14% of total complications). Some form of operative treatment or explantation was performed for 51.43% and 34.29% of complications, respectively. External distractors and related hardware made up 8.6% of reports and the most common complication in this group was the screw backing out at 33.3% of all reports. Conclusions: The MAUDE database is a useful tool in evaluation of MDO device-related incidents. Most complications occur in the postoperative period, during the distraction phase, and often require device removal. The most common complication in external distractors was screws backing out. Mindful activation of the distractor, careful device/screw handling, technical improvement of the devices, and thorough preoperative planning may minimize these untoward events.

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Section: Discussionmentioning

confidence: 99%

“…Intraoperative or postoperative failure of these devices does occur and may require revision surgery and device reinsertion. 3 -5…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Complications of Pediatric Mandibular Distraction Osteogenesis Hardware: A 10-Year Retrospective Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Jinka

Coombs

Murthy

2022

FACE

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Current Approaches in Vertical Bone Augmentation and Large Bone Deficiencies in the Orofacial Region

Vaquette¹,

Ivanovski²,

Batstone³

2023

Regenerative Medicine

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Feasibility of Parylene C for encapsulating piezoelectric actuators in active medical implants

Kohler,

Blendinger,

Müller

et al. 2023

Front. Med. Technol.

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Parylene C is well-known as an encapsulation material for medical implants. Within the approach of miniaturization and automatization of a bone distractor, piezoelectric actuators were encapsulated with Parylene C. The stretchability of the polymer was investigated with respect to the encapsulation functionality of piezoelectric chips. We determined a linear yield strain of 1% of approximately 12-µm-thick Parylene C foil. Parylene C encapsulation withstands the mechanical stress of a minimum of 5×105 duty cycles by continuous actuation. The experiments demonstrate that elongation of the encapsulation on piezoelectric actuators and thus the elongation of Parylene C up to 0.8 mm are feasible.

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Complications of distraction osteogenesis: Narrative review

Cited by 3 publications

References 32 publications

Complications of Pediatric Mandibular Distraction Osteogenesis Hardware: A 10-Year Retrospective Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Complications of Pediatric Mandibular Distraction Osteogenesis Hardware: A 10-Year Retrospective Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Current Approaches in Vertical Bone Augmentation and Large Bone Deficiencies in the Orofacial Region

Feasibility of Parylene C for encapsulating piezoelectric actuators in active medical implants

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