MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, RIGHT, 5+17-HOLES, WITH TEMPLATE; IMPLANT

Model Number	55-15920
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
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 plate that was placed for reconstruction of a right mandibular tumor broke.There was revision surgery to replace the plate.
Event or Problem Description
It was reported that a plate that was placed for reconstruction of a right mandibular tumor broke.There was revision surgery to replace the plate.
Additional Manufacturer Narrative
The investigation results show that the postoperative plate fracture occurred through a bar, so the reported event could be confirmed.The measurable dimensions and chemical composition of the returned plate are in accordance with the specifications.The macroscopic appearance points to exceeding the material strength.That is confirmed by the deterioration of the anodization layer and the changes of the surface¿s structure in the area of the breakage.Strong plastic deformation with material bulging indicate high forces acted on the plate during application / removal.Further some marks/scratches are visible from instruments used in application.The fracture surfaces were partially leveled due to friction with the counterpart.The non-destroyed fracture surfaces (rest) show the appearance of a low cycle fatigue rupture.The fractographic investigation with sem shows a structure of a low cycle fatigue rupture with secondary cracks and in addition, swinging lines of a fatigue breakage are visible.All further information provided did not indicate any deviation from the user¿s instruction.Based on the performed investigation, there is no indication for an incorrectly working product or any systematic design, material, or manufacturing related issue.

• Brand Name: PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, RIGHT, 5+17-HOLES, WITH TEMPLATE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13003835
• Report Number: 0008010177-2021-00053
• Device Sequence Number: 11236279
• Product Code: JEY
• UDI-Device Identifier: 04546540356390
• UDI-Public: 04546540356390
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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
• Device Model Number: 55-15920
• Device Catalogue Number: 55-15920
• Device Lot Number: 306577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown