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

Model Number	78-50040
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	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the implant needed to be burred down due to the device not sitting flush with the bone.There was no significant surgery delay and the surgery was completed successfully with no adverse events to the patient.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : implanted.
Event or Problem Description
It was reported that during the procedure the implant needed to be burred down due to the device not sitting flush with the bone.There was no significant surgery delay and the surgery was completed successfully with no adverse events to the patient.
Additional Manufacturer Narrative
Update: h4, h6.The reported event could not be confirmed as no intra-operative images were provided.A sketch was provided, which indicated that the peek implant required modification in the inferior/posterior area of the implant near the lambdoidal suture, not near sagittal suture as initially reported.The implant was burred down in this area.In the analysis of the peek design, it was found that the ct scan provided for implant designwas taken on (b)(6) 2019.Thus, the scan was approx.3 years and 11 months old at the time of surgery.A respective ct age warning was placed in the design proposal.During this period of time anatomical changes can occur and may require modification to the implant.Likely root causes that were identified are anatomical changes or the formation of calcifications on the defect¿s edges.For further investigation, a post-op ct scan would be required, which was not provided.Overall, no deviation in the implant design was found.The implant was designed as requested by the customer and according to all quality instructions.Further, the dhr rereview showed that the implant was manufactured to specification.H3 other text : not available.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, XL
• 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: 17183204
• Report Number: 0008010177-2023-00044
• Device Sequence Number: 6518479
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/07/2023

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: 78-50040
• Device Catalogue Number: 78-50040
• Device Lot Number: 2305171065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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