MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG RECON HEMI MANDIBULAR PLATTE, 6X17 HOLE, LEFT, WITH TEMPLATE; IMPLANT

Catalog Number	55-28922
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device is implanted in patient.
Event or Problem Description
It was reported by a surgeon that during a post-surgical appointment it was found an implant plate had broken post-operatively.There is no additional information available such as what happened with the original procedure, how the plate broke, or if a revision surgery is planned, but eventual medical intervention is assumed.
Additional Manufacturer Narrative
The reported device was not returned for evaluation.However, as images of the postoperative plate break-age has been received, the event could be confirmed.The plate has broken in-between screw holes.The sales rep mentioned that the plate was implanted on (b)(6) 2017.The plate broke on (b)(6) 2018.The surgeon was not sure whether the patient was following all post-op instructions, although it was mentioned that the patient was supposedly following a soft food diet.The patient did not return for follow-up after the plate breakage was determined.A review of the device history records verify that all the processing steps were performed according to specification.The provided post-operative x-ray shows that in order to fix the plate the surgeon used three 2.3 mm screws on each side of the segmental gap.This was the minimum number of screws according to the related instructions for use (90-01939, rev.8, (b)(6) 2018).The following are possible root causes according to the related risk management file: - too much load on implant/ bone - abnormal mental/ physiological condition of patient - implant was damaged by instrument/screw during bending/shaping/insertion the investigation results of pi 1399056 could confirm that plate breakage could occur due to overload.This is confirmed by previous investigations (e.G.Pi 1399056 ¿ complaint (b)(4) ¿ investigation (b)(4)) where it was determined that post-operative plate breakages occurred as a result of one or repeated powerful dynamically overload of the fracture area of the plate.Based on the statistical evaluation, there is no indication for an incorrectly working product or any systematic design, material, or manufacturing related issue.Therefore, no further corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.Should the device be returned at a later date or further information has been received, the investigation will be re-evaluated accordingly.
Event or Problem Description
It was reported by a surgeon that during a post-surgical appointment it was found an implant plate had broken post-operatively.There is no additional information available such as what happened with the original procedure, how the plate broke, or if a revision surgery is planned, but eventual medical intervention is assumed.

• Brand Name: RECON HEMI MANDIBULAR PLATTE, 6X17 HOLE, LEFT, WITH TEMPLATE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8632455
• Report Number: 0008010177-2019-00022
• Device Sequence Number: 1655758
• Product Code: JEY
• UDI-Device Identifier: 04546540356444
• UDI-Public: 04546540356444
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: 55-28922
• Device Lot Number: 1000215456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1