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

Catalog Number	78-40030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735)
Date of Event	03/13/2024
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.H3 other text : not available.
Event or Problem Description
It was reported there was a revision surgery performed to revise the implant due to patient presenting with a wound dehiscence.
Additional Manufacturer Narrative
Update: h6 the device history records for the reported catalog and lot number, indicate that one unit was manufactured to specification.A proper sterilization was followed and fitting issue was not reported.The case was presented to stryker's medical expert and he stated if the implant fit well, it did not cause dehiscence.Therefore, the device did not cause or contribute to the event.There is no indication of an incorrectly working device or manufacturing-related issue.
Event or Problem Description
It was reported there was a revision surgery performed to revise the implant due to patient presenting with a wound dehiscence.

• 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: 19082144
• Report Number: 0008010177-2024-00026
• Device Sequence Number: 20738295
• Product Code: GWO
• UDI-Device Identifier: 07613327129298
• UDI-Public: 07613327129298
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 78-40030
• Device Lot Number: 2304251007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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