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

Model Number	78-50030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Cerebral Edema (4403); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant did not fit as expected and was modified to fit and the surgery was completed successfully.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device implanted.
Additional Manufacturer Narrative
The reported event could be confirmed as an intra-operative video and photos were provided, which show the device not fitting into the defect.The video showed that when the implant is aligning with the posterior edge of the defect, there is a gap anteriorly, and vice versa.The peek cci design team performed an analysis of the implant design and all quality relevant steps for the peek device under complaint.It showed that all steps were performed in accordance to the applicable freqi procedures.The implant is designed as it got requested through erequest.In addition, the provided ct scan from the day before surgery was evaluated, and the peek implant digitally inserted and aligned with the defect.This analysis showed swelling in the temporal area, where the implant required modifications intra-operatively.This finding was discussed with stryker r&d and it was noted that it is consistent with the observations from the intra-operative video.In the presence of swelling, the implant sits on the brain and thus rocks anteriorly/posteriorly.In conclusion, the implant was designed as requested by the customer and according to all quality instructions.Further, the dhr review showed that the implant was manufactured to specification.Per the investigation performed above, the reported event can be attributed to swelling that was still present in the temporal area during surgery.Based on the investigation steps performed, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issue.H3 other text: implanted.
Event or Problem Description
It was reported that the implant did not fit as expected and was modified to fit and the surgery was completed successfully.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT PRIORITY, L
• 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: 15372674
• Report Number: 0008010177-2022-00030
• Device Sequence Number: 15022105
• Product Code: GWO
• UDI-Device Identifier: 07613327129267
• UDI-Public: 07613327129267
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 78-50030
• Device Catalogue Number: 78-50030
• Device Lot Number: 2111301003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2022
• Supplement Date Received by Manufacturer: 08/27/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female