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

Model Number	78-10010
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
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.
Event or Problem Description
It was reported that the peek implant did not fit as expected, it was too large.The surgeon needed to modify the implant to fit the patient.There were no adverse consequences to the patient and no surgery delay reported.
Additional Manufacturer Narrative
Updated: h4, h6 device is not available for evaluation however, intra-op pictures were provided as well as the design review; therefore, a root cause was determined.
Event or Problem Description
It was reported that the peek implant did not fit as expected, it was too large.The surgeon needed to modify the implant to fit the patient.There were no adverse consequences to the patient and no surgery delay reported.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, S
• 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: 16762144
• Report Number: 0008010177-2023-00020
• Device Sequence Number: 3034385
• Product Code: GWO
• UDI-Device Identifier: 04546540730763
• UDI-Public: 04546540730763
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: 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
• Device Model Number: 78-10010
• Device Catalogue Number: 78-10010
• Device Lot Number: 2212141008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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: Female