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	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the cranioplasty, the surgeon noticed the peek implant could not be placed on the bone as planned.The implant had the right shape, but it was too thick to be able to touch the patient¿s bone and was resting on the brain.Surgeon had to install the implant with the offset.There is no known postoperative damage at this time.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed as intraoperative images were provided showing the compromised fit of the implant and a gap between the defect¿s void and the implant¿s contour.The highlighted bone cement residuals were reported to be fully removed.Still, the contour seemed to have the right shape, but the implant was too thick.Thus, the implant was installed with an offset.No delay or adverse consequences were reported.In conclusion, the implant was designed as requested by the customer.Possible contributing factors are assumed to be swelling of the brain, partial removal of the bone cement residuals, and the resulting (high) implant thickness due to the request of mirroring the contralateral side.Overall, the implant was designed according to all quality instructions, and manufactured to specification.Based on the investigation steps performed, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and /or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.H3 other text : device not available.
Event or Problem Description
It was reported that during the cranioplasty, the surgeon noticed the peek implant could not be placed on the bone as planned.The implant had the right shape, but it was too thick to be able to touch the patient¿s bone and was resting on the brain.Surgeon had to install the implant with the offset.There is no known postoperative damage at this time.

• 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 ; 76145120
• MDR Report Key: 14308784
• Report Number: 0008010177-2022-00015
• Device Sequence Number: 5273748
• Product Code: GWO
• UDI-Device Identifier: 07613327129274
• UDI-Public: 07613327129274
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 2203281008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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