MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR PRIORITY CUSTOMIZED MANDIBLE AUG; IMPLANT

Catalog Number	5444-4-610
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	06/18/2024
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
It was reported by the surgeon that during the procedure, the custom implant did not fit as expected.The design drawings appeared to be accurate however, the implants dimensions/features do not match.
Event or Problem Description
It was reported by the surgeon that during the procedure, the custom implant did not fit as expected.The design drawings appeared to be accurate however, the implants dimensions/features do not match.
Additional Manufacturer Narrative
The reported issue of the customized implant not fitting as expected was confirmed to be due to incorrect implantation by the surgeon.The implant was placed with the wrong orientation.Contact with the stryker sales representative revealed that the implant was used despite a possible surgical delay of two hours, and no revision surgery is planned.A device history record (dhr) review was conducted, and no deviations were found; all required tests were passed without discrepancies.A design analysis confirmed that the implant was manufactured according to the approved design proposal, with no deviations from the standard design process.The root cause of the issue was determined to be the surgeon's failure to follow the design proposal, resulting in the incorrect fit.Based on the investigation, there is no evidence of a product defect or any design, material, or manufacturing issues.

• Brand Name: MEDPOR PRIORITY CUSTOMIZED MANDIBLE AUG
• 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: 19639037
• Report Number: 0008010177-2024-00054
• Device Sequence Number: 7146246
• Product Code: FWP
• UDI-Device Identifier: 07613327466461
• UDI-Public: 07613327466461
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191916
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 5444-4-610
• Device Lot Number: 2406031059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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