MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING L-PLATE, WITH 8MM BAR, 6 HOLE, MIDFACE; IMPANT

Catalog Number	55-05765
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
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 months 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 be confirmed: the returned plate shows a fracture.The plate was returned in order to determine the root cause of the failure.The sample was examined regarding its dimensions, chemical composition (edx analysis) and by light and scanning electron microscopy.Due to the (measurable) dimensions the reported catalog number of the plate could be confirmed.The chemical composition conforms to the specification titanium grade 2.The postoperative plate fracture occurred through a fixing hole.The macroscopic appearance points to exceeding the material strength due to very high forces.That is confirmed by the deterioration of the anodization layer, the changes of the surface¿s structure and the secondary cracks in the area of the breakage.Two of the fracture surfaces (a and c) were partially leveled due to friction with the counterpart.The non-destroyed fracture surface (rest) (a and c) and the other two fracture surfaces (b and d) show the appearance of a forced rupture.The fractographic investigation with sem shows a structure of a low cycle fatigue rupture with secondary cracks.In addition, swinging lines of a fatigue breakage are visible.The deformed plate holes signify not only an increased risk of breakage in these areas but also impair the accurate fit of the screw head to the plate.The strong damages caused by the screw had led to a massive local strain hardening / embrittlement of the material and has considerably contributed to the breakage of the plate.The device history record for catalog # 55-05765 ¿locking l-plate, with 8mm bar, 6 hole, midface¿, lot code #1000117908 indicates 100 units were manufactured to specification and accepted into final stock on 2014-feb-14 with no reported discrepancies.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.
Event or Problem Description
It was reported that a 6 months 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 8MM BAR, 6 HOLE, MIDFACE
• Common Device Name: IMPANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7986496
• Report Number: 0008010177-2018-00105
• Device Sequence Number: 11156044
• Product Code: JEY
• UDI-Device Identifier: 04546540365712
• UDI-Public: 04546540365712
• 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): 03/29/2019

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: 55-05765
• Device Lot Number: 1000119550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 03/29/2019
• 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