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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Implanted.
Event or Problem Description
It was reported that the implant did not fit as expected and the implant had to be cut in the posterior section.
Additional Manufacturer Narrative
Device is not available for evaluation and the reported event could not be confirmed.If additional information is received, a supplemental report will be filed.H3 other text: not available.
Event or Problem Description
It was reported that the implant did not fit as expected and the implant had to be cut in the posterior section.

• 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 ; 7614888208
• MDR Report Key: 16682826
• Report Number: 0008010177-2023-00018
• Device Sequence Number: 7950175
• Product Code: GWO
• UDI-Device Identifier: 04546540730787
• UDI-Public: 04546540730787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 78-10030
• Device Catalogue Number: 78-10030
• Device Lot Number: 2302151030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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
• Patient Sex: Unknown