BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMF CUSTOMIZED IMPLANT KIT LARGE

    MDR report key: 3817585 · Received May 19, 2014

    Report

    Report Number
    0002249697-2014-01860
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KKY
    PMA / PMN Number
    K103010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED FROM PROVIDED PHOTOS, BUT THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED.A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT.VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT CRANIOPLASTY RECONSTRUCTION SURGERY WITH A LARGE PMMA CUSTOM IMPLANT (5444-0-300), THE CUSTOM IMPLANT WAS SUPPOSE TO COVER MOST OF THE LEFT SIDE OF THE SKULL AND TEMPORAL AREA. THE FRONT AND BOTTOM OF THE IMPLANT WERE NOT THE CORRECT CONTOUR OR SIZE. THEY HAD TO CUT THE BOTTOM FROM ONE OF THE STERILE IMPLANTS (TWO ARE PROVIDED IN THE BOX) AND PIECE IT TOGETHER WITH MESH, CDSLM57, AND 55 SCREWS. THERE WAS A SURGICAL DELAY OF 1 HOUR AND 45 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT CRANIOPLASTY RECONSTRUCTION SURGERY WITH A LARGE PMMA CUSTOM IMPLANT ((B)(4)), THE CUSTOM IMPLANT WAS SUPPOSE TO COVER MOST OF THE LEFT SIDE OF THE SKULL AND TEMPORAL AREA. THE FRONT AND BOTTOM OF THE IMPLANT WERE NOT THE CORRECT CONTOUR OR SIZE. THEY HAD TO CUT THE BOTTOM FROM ONE OF THE STERILE IMPLANTS (TWO ARE PROVIDED IN THE BOX) AND PIECE IT TOGETHER WITH MESH, CDSLM57, AND 55 SCREWS. THERE WAS A SURGICAL DELAY OF 1 HOUR AND 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296936 CMF CUSTOMIZED IMPLANT KIT LARGE IMPLANT KKY STRYKER ORTHOPAEDICS-MAHWAH K000009278

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other