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

Model Number	78-10030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Insufficient Information (4580)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the peek implant did not fit as expected and needed to be modified to complete the surgery.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Additional Manufacturer Narrative
The reported event can be confirmed as intra-operative photos were provided, which showed the implant not fitting to the defect properly.The peek cci design team performed an analysis of the implant design and all quality relevant steps for the peek device under complaint.It showed that all steps were performed in accordance to the applicable freqi procedures.The implant is designed as it got requested through erequest.The implant was rotated in a way that the implant rests on the segmented bone fragments/calcifications, which replicated the observed gap as described in the intake.Overall, the event is likely attributed to the bone calcifications not being removed prior to inserting the peek implant.This was confirmed by the sales representative and the situation in surgery could be replicated virtually in the design analysis.
Event or Problem Description
It was reported that the peek implant did not fit as expected and needed to be modified to complete the surgery.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, 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 ; 76145120
• MDR Report Key: 14981159
• Report Number: 0008010177-2022-00022
• Device Sequence Number: 5666099
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 78-10030
• Device Catalogue Number: 78-10030
• Device Lot Number: 2204201049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 10/13/2022
• 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