MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT KIT, S

Catalog Number	78-10010
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	07/07/2023
Type of Reportable Event	Malfunction
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 : device implanted.
Event or Problem Description
It was reported during the surgery that the implant did not fit as expected; it was too thick and did not fit flush.The surgeon ended up burring down the implant and used it to complete the surgery.
Event or Problem Description
It was reported during the surgery that the implant did not fit as expected; it was too thick and did not fit flush.The surgeon ended up burring down the implant and used it to complete the surgery.
Additional Manufacturer Narrative
Updated: h4, h6.The implant did not fit correctly and bone was present in an area where a hole was supposed to be.As a result, the implant was thicker than expected.Surgeon burred the implant, and a surgical delay of 30 minutes was reported.The investigation found that the implant was correctly designed and the manufacturing analysis showed no deviations.Also, the implant does not intersect with any bone as shown in the design proposal.It is most likely that the defect has changed since the scan was taken and the implant did not adapt to the new anatomy.Over time a new bone has formed over the defect area.In conclusion, the peek was designed according and manufactured according to specification.No device problem could be found.H3 other text : implanted.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT KIT, S
• 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: 17397545
• Report Number: 0008010177-2023-00052
• Device Sequence Number: 18031409
• Product Code: GWO
• UDI-Device Identifier: 04546540730763
• UDI-Public: 04546540730763
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121153
• 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): 10/31/2023

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 Catalogue Number: 78-10010
• Device Lot Number: 2305121012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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