BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMF CUSTOMIZED IMPLANT KIT X-LARGE

    MDR report key: 2843645 · Received October 25, 2012

    Report

    Report Number
    2249697-2012-02084
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KKY
    PMA / PMN Number
    K103010
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - REVIEW OF 2 IMAGES OF THE MODIFIED IMPLANT, APPROVED DESIGN PROPOSAL FOR CASE (B)(4) CONTAINING THE PRE-OPERATIVE CT SCANS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. REVIEW OF THE DESIGN PROPOSAL INDICATED THE DEVICE WAS MANUFACTURED ACCORDING TO THE (B)(4). THE SURGEON APPROVED THE DESIGN PROPOSAL AS IS INDICATING SATISFACTION WITH THE PROPOSED IMPLANT PROFILE AND SIZE. IT WAS DETERMINED THE DEVICE FIT CORRECTLY IN THE PROVIDED HOST BONE MODEL WHEN TESTED DURING SURGERY. VISUAL INSPECTION OF THE PROVIDED IMAGES INDICATES THE DEVICE WAS HEAVILY MODIFIED DURING THE OPERATION. DISCUSSION WITH THE CUSTOM CRANIAL IMPLANT DESIGN TEAM INDICATED THAT THE SIZE OF THE IMPLANT MAY HAVE AFFECTED THE SURGEON'S PERCEPTION OF THE PROPER FIT OF THE IMPLANT. DEVICE HISTORY REVIEW DETERMINED THE DEVICE WAS MANUFACTURED WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE DESIGN PROPOSAL FOR THE CASE INDICATED THAT THE DESIGN WAS COMPLETED AND REVIEWED ACCORDING TO ALL APPLICABLE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE IMPLANT DID NOT FIT THE DEFECT CORRECTLY. THE SURGEON HAD TO MODIFY THE IMPLANT INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMF CUSTOMIZED IMPLANT KIT X-LARGE IMPLANT KKY STRYKER ORTHOPAEDICS MAHWAH NA K08286SR11MAY

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other