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

Catalog Number	78-10020
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the original surgery to place the implant was completed successfully.One week post operative, the patient felt a gap inferiorly on both the anterior and posterior aspects of the implant.
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 : implanted.
Additional Manufacturer Narrative
It was reported by the sales rep that the surgeon stated that the implant fit really well during the case.A week later the patient mentioned feeling a gap inferiorly on both the anterior and posterior aspects of the implant.The case was reviewed by stryker¿s design team.It was stated that the implant was designed as requested and the implant outer surface was reduced per surgeon¿s request.All margins of the implant fit the patient¿s defect perfectly with the standard clearance of 0.5mm.There are no intentional nor technical gaps present in the design as shown on the design proposal.Further, as the surgeon stated that the implant fit perfectly during implantation, it is possible that other complications arose after surgery.Conclusively, the peek implant¿s fit was not compromised, and the device worked as intended.Thus, this event does not meet complaint requirements.
Event or Problem Description
It was reported that the original surgery to place the implant was completed successfully.One week post operative, the patient felt a gap inferiorly on both the anterior and posterior aspects of the implant.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, M
• 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: 18006964
• Report Number: 0008010177-2023-00066
• Device Sequence Number: 7702832
• Product Code: GWO
• UDI-Device Identifier: 07613327004021
• UDI-Public: 07613327004021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 78-10020
• Device Lot Number: 2307261001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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