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

Catalog Number	78-50030
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	03/19/2024
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.
Event or Problem Description
The stryker representative reported that during the procedure, it was noticed the posterior inferior edge did not fit as expected.
Additional Manufacturer Narrative
The reported event could not be confirmed as no post op ct scans or photos were provided for review.As described in the event description, the sales rep stated that it was noticed during the procedure, the very most posterior inferior edge sat a little proud.However, it was reported that this did not cause any adverse consequences for the patient or any surgical delay.The manufacturing documents were reviewed and showed no deviations.In 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.
Event or Problem Description
The stryker representative reported that during the procedure, it was noticed the posterior inferior edge did not fit as expected.

• Brand Name: PEEK PRIORITY CUST IMPL LARGE
• 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: 19095876
• Report Number: 0008010177-2024-00029
• Device Sequence Number: 7408472
• Product Code: GWO
• UDI-Device Identifier: 07613327129267
• UDI-Public: 07613327129267
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 78-50030
• Device Lot Number: 2312111016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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