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	Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by the company representative that the custom implant did not fit properly.The surgery was not completed and implant was not used.There is no other information known at this time.
Event or Problem Description
It was reported by the company representative that the custom implant did not fit properly.The surgery was not completed and implant was not used.There is no other information known at this time.
Additional Manufacturer Narrative
The reported failure mode could not be confirmed, as no photos of the implant not fitting into the void during surgery were provided.Additional information was provided by the sales rep on the reported event that the implant would not sit properly.When pushing down the implant anteriorly to the point that it sits flush with the anterior void, it would pop up posteriorly up to 1 inch (and vice versa).Swelling was present during the case, and the sales rep made the surgeon aware of the presence of swelling prior surgery.The surgeon disliked the symmetric design of the implant and expected it to be designed more convex shaped to allow the swelling more space.Overall, the device was not implanted, and the surgery aborted.The prolongation of the surgery was 1h ¿ 1,5h.Further treatment plan for the patient has not been determined.No revision device was ordered for this patient at the point this investigation is completed.The device was returned for evaluation and an analysis of the implant design and all quality relevant steps was performed by the peek cci design team for the implant under complaint (id 2107091033).It showed that all ¿steps were performed in accordance to [our] freqi procedures.The implant is designed as requested through erequest.¿ the scan provided was 3 days old when the implant was designed, and swelling was very present in the scan.Therefore, an additional note was placed on p.5 of the design proposal pointing out the presence of swelling.The implant itself was designed symmetric to the contralateral side.The designers may raise awareness notes in the design proposal to highlight potential difficulties (e.G.Presence of swelling).In conclusion, the implant was designed as requested by the customer and the root cause can be attributed to the patient condition and the swelling that was still present during surgery.Overall, the implant was designed according to all quality instructions, and manufactured to specification.

• 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 ; 76145120
• MDR Report Key: 12319899
• Report Number: 0008010177-2021-00040
• Device Sequence Number: 17301462
• Product Code: GWO
• UDI-Device Identifier: 07613327129267
• UDI-Public: 07613327129267
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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 Model Number: 78-50030
• Device Catalogue Number: 78-50030
• Device Lot Number: 2107091033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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
• Patient Sex: Unknown