MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: MATRIXORTHOGNATHIC; PLATE, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: matrixorthognathic /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: lee, c.C.Et al.(2021), variables associated with stability after le fort i osteotomy for skeletal class iii malocclusion, international association of oral and maxillofacial surgeons, vol.Xx, pages 1-7 (usa).The purpose of this study was to assess skeletal stability and predictors of relapse in patients undergoing an isolated le fort i osteotomy.Between 2004 and 2018, a total of 314 patients underwent a single jaw le fort i osteotomy with or without segmentation using pre-bent orthognathic plates (matrix orthognathic, depuy synthes/j&j medical devices, new brunswick, nj, usa).The mean and median ages were 26.5 +/ 9.0 years and 24 years, respectively.The mean and median duration of follow up was 2.65 +/ 2.51 years and 1.55 years, respectively.Follow-up time ranged from 0.79 to 11.3 years.The following complications were reported: a (b)(6)-year-old female patient required reoperation after 13 months for fibrous union secondary to bruxism, though her skeletal position and occlusion remained stable at the time of her re-operation and to latest follow-up.There were no re-operations for subject or surgeon dissatisfaction with skeletal stability/relapse.8 patients had potentially clinically significant relapse (2¿4 mm) in the sagittal plane, and 1 patient in the vertical plane.1 patient had >4 mm of skeletal relapse in the vertical plane, though this occurred after debridement and additional bone grafting as the patient developed osteomyelitis 2 years postoperatively in the area of an allograft placed at the midline between segments.Most relapse occurred within the first 1¿2 postoperative years.14 patients had an overbite or overjet outside a clinically acceptable range of 1¿4 mm at latest follow-up.Of these subjects, only one had potentially clinically significant skeletal relapse.This report is for an unknown synthes pre-bent orthognathic plates (matrix orthognathic).This report is for (1) unk - plates: matrixorthognathic.This report is 1 of 4 for (b)(4).

• Brand Name: UNK - PLATES: MATRIXORTHOGNATHIC
• Type of Device: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12281657
• MDR Text Key: 265210217
• Report Number: 2939274-2021-04504
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention