MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; BONE PLATE

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Thirty-nine (39) patients (22 male, 17 female, average age 4 years 10 months).Date of event: unknown.Implant date: unknown.Explant date: 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: an, jingang.Et al (2015), application of biodegradable plates for treating pediatric mandibular fractures, journal of cranio-maxillo-facial surgery vol.43 (2015), pages 515-520.(china) the purpose of the study was to summarize and analyze the results of biodegradable fixation of pediatric mandibular fractures, and observe the imaging findings for fracture repair and bone changes around the biodegradable plates and screws during follow-up.Thirty-nine (39) patients (22 male, 17 female, average age 4 years 10 months) with different mandibular fractures and who underwent open reduction internal fixation (orif) from september 2008 to december 2013 were studied.Synthes biodegradable/ resorbable plates (polymax) composed of the material polyl-lactide-co-glycolide (plga) with 2.0-mm screws were used to repair the fractures.Patients were followed at 1, 3, and 6 months, and postoperative follow-up ranged from 6 months to 5 years.Twenty (20) patients underwent one or more computed tomography (ct) examinations during the entire follow-up period.The following complications were reported: two cases of left parasymphysis fracture combined with right condylar fracture developed small fistulas at the intraoral incision 2 months after surgery.The fistulas healed after 1 month without special treatment.All 20 patients who underwent the ct examinations during follow-up developed osteolysis at the site as early as 1 month after surgery.The extent and depth of the regions were obvious within 1 year after surgery, and the bone underlying the plates were clearly irregular and depressed when compared with the adjacent bones.In the second year, there were obvious repairs to the regions and the bony defect areas had become shallower.After 2 years, the bony defect areas had almost disappeared.A (b)(6) boy who sustained symphysis and bilateral condylar fractures from a high fall developed severe osteolysis at the biodegradable fixation site which was detected through a 3-dimensional ct scan 6 months post-operation (fig.5.C of the article).Two and a half (2.5) years after the operation, the fracture site showed good reossification at the osteolytic region.A (b)(6) girl who sustained a left parasymphysis fracture from a traffic accident developed bone resorption around the plate and the fracture line one (1) month after the operation.A ct scan 6 months after the operation revealed there was no obvious change to the bone depression area, but the fracture healing was good.(fig.4.C of the article) a boy (b)(6) who sustained symphysis and right condylar fractures developed slight local osteolysis at the biodegradable fixation site 10 months after the surgery, which persisted 1.5 years after surgery.This report is for an unknown synthes polymax resorbable fixation system.This report captures the reported (b)(6) boy who developed severe osteolysis at the biodegradable fixation site.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.B5: attached literature article.

• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 7642282
• MDR Text Key: 112550099
• Report Number: 8030965-2018-54667
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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: 04/11/2023
• 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
• Patient Age: 2 YR
• Patient Sex: Male