MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM; BONE PLATE

Catalog Number 04.511.205.01C

Device Problem Malposition of Device (2616)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Exact date is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Product was not returned.Device history records review could not be completed without lot number.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient had a bilateral sagittal split osteotomy of the mandible using a trumatch mandible plate and a titanium matrixorthognathic self-tapping screws.However, on (b)(6) 2019, the patient was presented with a post-operative infection associated with the mandibular plate on both sides.There is a concern about the closeness of the posterior screws to each other which may increase the risk of bone necrosis due to a reduction in blood supply.There is also a concern about the closeness of the plate to the buccal incision margin as this may increase the risk of infection.The patient was given with an amoxycillin and flagyl for antibiotics and was to be checked again on (b)(6) 2019.There has been no change in antibiotic protocol, suturing technique or irrigation protocol and in the cleaning/sterilization protocols.There are no plans to remove the implant at this stage.The plate cannot be removed as too soon after surgery so infection needs to be controlled with antibiotics until bony union occurs.Patient outcome is unknown.This (b)(4) is the initial complaint that captures the 1-8 screws while (b)(4) captures 9-16 screws.This report is for one (1) 1.85mm ti matrix screw.This is report 1 of 8 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.For this complaint, the device history records of the five infection cases were reviewed.The bsso plates were designed according to the work instructions.As such, the work instructions on screw placement and plate design were reviewed.In the applicable time frame, the work instructions were updated to adjust the maximum distance between the screws.As the minimum screw distance remained, this change would not affect the issue stated by the complainant.No changes affected the biocompatibility or cleaning process of the devices.Process changes and relevant actions initiated in the appropriate time frame were evaluated.As the surgeon indicated, some of the infections probably occurred due to inadequate wound closure.However, this cannot be confirmed nor excluded based on the available information and it does not explain the other infection complaints.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.

• Brand Name: 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8428908
• MDR Text Key: 139089307
• Report Number: 8030965-2019-62011
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819358126
• UDI-Public: (01)07611819358126
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.205.01C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR