MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING L-PLATE, WITH 5MM BAR, 5 HOLE, MIDFACE; IMPANT

Catalog Number	55-05763
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that a 6 month postoperative clinical examination showed mobility of the maxillary bone.On (b)(6) 2018 a new surgical procedure was performed to evaluate the fixation of the jaw and a fracture of the 2 fixation plates was observed on the left side.
Additional Manufacturer Narrative
The reported event could not be confirmed, because the affected device was not returned.Additional information (e.G.Postoperative images during implantation and at the time the event has been discovered were requested) has been requested in order to provide more details to the reported event.The distributor has forwarded the requested postoperative images and also mentioned that the patient was compliant to postoperative care instructions.The device has been implanted on (b)(6) 2018.During a postoperative clinical examination 6 months after the procedure, it has been observed that there is movement of the maxillary bone.Plate breakage has been confirmed on (b)(6) 2018, 8 months after implantation.In the instructions for use, it is stated that ¿(¿) the implants are designed to function only until bony healing (usually 6-10 weeks).(¿)¿ further.The review of the related dhr of the plate in question has shown that the device was manufactured to specification and has been accepted in final stock without any reported discrepancies.The possible root causes in the corresponding risk management file are: wrong/ missing information, too much load on implant/ bone (e.G.Due to tmj disorder/disease), improper insertion/ positioning of implant, wrong implant placement (e.G.Region with reduced bone quality, too much bone compression during screw insertion), implant was damaged by instrument/screw during bending/shaping/insertion, implant damaged during sterilization (e.G.Gamma radiation), wrong choice of implant (e.G.Screw too short due to system mixup and / or poorly assembled/used instrument or misleading measuring/identification).Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.Therefore no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.Should the device be returned, the investigation will be re-evaluated.
Event or Problem Description
It was reported that a 6 month postoperative clinical examination showed mobility of the maxillary bone.On (b)(6) 2018 a new surgical procedure was performed to evaluate the fixation of the jaw and a fracture of the 2 fixation plates was observed on the left side.

• Brand Name: LOCKING L-PLATE, WITH 5MM BAR, 5 HOLE, MIDFACE
• Common Device Name: IMPANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7965318
• Report Number: 0008010177-2018-00101
• Device Sequence Number: 11151002
• Product Code: JEY
• UDI-Device Identifier: 04546540365705
• UDI-Public: 04546540365705
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 55-05763
• Device Lot Number: 1000117908
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention