MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING PLATE, SAGITTAL SPLIT, STRAIGHT, 12MM BAR, 6 HOLE, ORTHIOGNATHIC; IMPLANT

Catalog Number	55-10566
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device was discarded at facility.
Event or Problem Description
It was reported that the plate broke three weeks after implantation and required a revision surgery to extract that plate and implant another.No additional adverse consequences were reported.
Additional Manufacturer Narrative
Corrected data: d10/h3 originally indicated that no return was to be made.The device was located and the actual device was, in fact, returned for evaluation.The reported event could be confirmed.In the detailed device inspection, it is stated that; ¿(¿) the investigation shows that the plate broke in low cycle fatigue mode by exceeding the material strength after a few cycles under partially very high forces.The strong plastic deformation with material bulging next to one breakage area also pointed to too high forces which acted on the plate during the application (¿)¿.Additional details regarding the reported event have been requested such as the type of procedure, postoperative x-rays during initial surgery, as well as surgery reports during implantation and explantation.In the surgery report during initial implantation, it is stated that the diagnosis was a right mandibular angle fracture.Stryker¿s medical expert has stated; ¿(¿) wrong plate used for the fracture.(¿)¿.The use of the reported plate to fix the fracture is considered as off-label use.Based on theperformed investigation, there is no indication of a product malfunction nor any systematic design, material or manufacturing related issue.
Event or Problem Description
It was reported that the plate broke three weeks after implantation and required a revision surgery to extract that plate and implant another.No additional adverse consequences were reported.

• Brand Name: LOCKING PLATE, SAGITTAL SPLIT, STRAIGHT, 12MM BAR, 6 HOLE, ORTHIOGNATHIC
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7899962
• Report Number: 0008010177-2018-00090
• Device Sequence Number: 13879736
• Product Code: JEY
• UDI-Device Identifier: 04546540366276
• UDI-Public: 04546540366276
• Combination Product (Y/N): N
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 55-10566
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 03/28/2019
• 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