MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE; IMPLANT

Model Number	55-15911
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plate was broken and a revision surgery was performed.
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.In addition to the primary mandibular reconstruction plate, 11-holes, with template (55-15911) there were also a total quantity of 5 reported screws (50-20412 and 50-20408 ) which are captured in complaints # (b)(4).
Additional Manufacturer Narrative
The reported event ¿breakage - postoperative¿ could be confirmed, because of the visual inspection.The macroscopic appearance points to exceeding the material strength.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.Strong plastic deformations with material bulging and a metal coil indicate high forces acted on the plate during application / removal.The lot numbers are not available, and no postoperative ct-scans or x-rays of the initial surgery can be provided.The senior global medical director stated the plate was inserted appropriately and for the correct indication.Based on the performed investigation, there is no indication for an incorrectly working product or any design, material or manufacturing related issue.
Event or Problem Description
It was reported that the plate was broken and a revision surgery was performed.

• Brand Name: PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 14697610
• Report Number: 0008010177-2022-00018
• Device Sequence Number: 6637199
• Product Code: JEY
• UDI-Device Identifier: 04546540356376
• UDI-Public: 04546540356376
• 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): 08/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: 55-15911
• Device Catalogue Number: 55-15911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2022
• Supplement Date Received by Manufacturer: 05/21/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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