MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUS. CRANIAL IMPL SMALL; IMPLANT

Catalog Number	78-10010
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	03/27/2024
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 it was noticed during surgery, when the implant was placed, there was a gap present.
Additional Manufacturer Narrative
Update: h6.The reported event could be confirmed with the provided intraoperative pictures.The investigation concluded there are several variables that may have contributed to the accuracy of fit, first being the orientation of the marking guide may have been set up different, leading to deviations.Another possibility is that the marking line itself may have been drawn at a different angle to the marking guide.Patient condition may have also lead to the inaccurate fit.In conclusion, the peek implant was designed and manufactured according to specification.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.
Event or Problem Description
It was reported that it was noticed during surgery, when the implant was placed, there was a gap present.

• Brand Name: PEEK CUS. CRANIAL IMPL SMALL
• 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: 19163697
• Report Number: 0008010177-2024-00032
• Device Sequence Number: 7948936
• Product Code: GWO
• UDI-Device Identifier: 04546540730763
• UDI-Public: 04546540730763
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/23/2024

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 Catalogue Number: 78-10010
• Device Lot Number: 2401311013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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
• Patient Sex: Unknown