MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, L

Catalog Number	78-40030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
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 the shape of the implant did not fit as expected and could not be used to complete the surgery.
Event or Problem Description
It was reported the shape of the implant did not fit as expected and could not be used to complete the surgery.
Additional Manufacturer Narrative
The reported event (implant did not fit and could therefore not be used) could be confirmed with the provided intraoperative pictures.A complaint analysis was performed by stryker¿s custom design team.A review of the intraoperative pictures as well as design plan showed brain swelling.Currently, the most plausible reason for the implant not fitting is the presence of brain swelling but no ultimate conclusion can be drawn without additional imaging.If any new information or scans alter this conclusion, the investigation will be reopened.In conclusion, the peek implant was designed according and manufactured according to specification.No device problem could be found.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, L
• 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 ; 7614888208
• MDR Report Key: 18943923
• Report Number: 0008010177-2024-00021
• Device Sequence Number: 19556731
• Product Code: GWO
• UDI-Device Identifier: 07613327129298
• UDI-Public: 07613327129298
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 78-40030
• Device Lot Number: 2311201015
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/19/2024
• 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: Other
• Patient Sex: Unknown