MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK PRIORITY CUST IMPL SMALL; IMPLANT

Catalog Number	78-50010
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	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure it was noticed the implant did not fit well.The surgeon had to burr the implant for it to fit.There was no significant delay in surgery, no adverse event reported, 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.H3 other text : implanted.
Event or Problem Description
It was reported that during the procedure it was noticed the implant did not fit well.The surgeon had to burr the implant for it to fit.There was no significant delay in surgery, no adverse event reported, and the surgery was completed successfully.
Additional Manufacturer Narrative
The reported event could not be confirmed as no post op ct scans or photos were provided for review.The manufacturing documents were reviewed and showed no deviations.A complaint analysis was performed by stryker¿s custom design team.The implant design and all quality relevant design steps were performed in accordance to the freqi procedures.The implant design was created with the requested features to fit the patient's defect.A medical expert was consulted who confirmed that in this case the size and shape of the defect may have evolved over the period of three months, necessitating a reshaping of the implant.With the confirmation of the medical expert, it can be concluded that most likely the implant did not fit due to bone growth between the scanning date and the date of the surgery.N conclusion, the peek implant was designed according and manufactured according to specification.No device problem could be found.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.

• Brand Name: PEEK PRIORITY CUST IMPL SMALL
• 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: 18888123
• Report Number: 0008010177-2024-00019
• Device Sequence Number: 7539678
• Product Code: GWO
• UDI-Device Identifier: 07613327129328
• UDI-Public: 07613327129328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 78-50010
• Device Lot Number: 2401101044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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