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

Catalog Number	78-50020
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that the implant was manufactured and did not meet the thickness specifications.There were no reported adverse events however, this product failure could cause or contribute to an adverse event should it happen again.
Additional Manufacturer Narrative
The reported event could be confirmed, as an image was provided by the design team.The investigation showed that the peek implant (id#: (b)(4) was sent on (b)(6).For this implant dedicated recessed areas for implant fixation were requested by the surgeon and an r&d evaluation was performed.The case was designed, manufactured and sent accordingly.On (b)(6), a remake of the exact same implant design but with dura suture holes was requested by the surgeon under id#: (b)(4).During this design phase, it was found that the first implant (b)(4) was thinner than the design limitation of 3.3 mm design in the recessed areas.This was missed in the first design phase as well as in the first performed r&d evaluation.No further action is required at this time.H3 other text: device has not been returned.
Event or Problem Description
It was reported that the implant was manufactured and did not meet the thickness specifications.There were no reported adverse events however, this product failure could cause or contribute to an adverse event should it happen again.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, 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: 18121963
• Report Number: 0008010177-2023-00070
• Device Sequence Number: 7016477
• Product Code: GWO
• UDI-Device Identifier: 07613327129281
• UDI-Public: 07613327129281
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 78-50020
• Device Lot Number: 2308241024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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
• Patient Sex: Unknown