MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED-PLUS-L; IMPLANT

Model Number	78-70030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant did not fit as expected.It appeared that the implant was too small.No further information is known at this time.
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.
Additional Manufacturer Narrative
The reported event could be confirmed, as intra-operative images and a video was received showing the issues during implantation.The implant was a peek pterional plus implant and was designed per standard procedure.No design session was held, and the implant was ordered without a host bone model.The implant¿s design was also assessed regarding the effect of brain swelling.Review of statements made by the surgeon and review of video received, found that swelling was not identified as an issue.In addition, an analysis of the implant design and all quality relevant steps was performed by the peek cci design team.It showed that all ¿steps were performed in accordance to [our] freqi procedures.No issue was found with the implant¿s design.This investigation results were shared with the sales representative during a web meeting.In addition, the peek device (engraved with ¿do not implant ¿ not for clinical use¿) and the manufactured host bone model were sent to the sales representative to assess the performed evaluation with the customer.A recommendation was given to the sales representative to encourage the surgeon to attend a design session in which all aspects of the peek implant can be discussed.Further, ordering a host bone model in addition to a peek pt.Plus implant was recommended for future cases.In conclusion, the implant was designed as requested by the customer.It was also designed according to all quality instructions and manufactured to specification.
Event or Problem Description
It was reported that the implant did not fit as expected.It appeared that the implant was too small.No further information is known at this time.

• Brand Name: PEEK CUSTOMIZED-PLUS-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: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 12839816
• Report Number: 0008010177-2021-00047
• Device Sequence Number: 4216919
• Product Code: GWO
• UDI-Device Identifier: 07613327300055
• UDI-Public: 07613327300055
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153248
• 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): 03/04/2022

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: 78-70030
• Device Catalogue Number: 78-70030
• Device Lot Number: 2110141005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2021
• 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