BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCANEUS STANDARD PLATE, MEDIUM

    MDR report key: 2172327 · Received June 23, 2011

    Report

    Report Number
    8010177-2011-00183
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K063875
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    WHILE SCREWING THE PLATE, A SCREW IN THE MOST SUPEROANTERIOR HOLE ON THE PLATE CONTINUED TO TRAVEL THROUGH THE PLATE. THE SCREW WAS 3.5MM IN DIAMETER. THE SURGEON HAD PERFORMED MINOR BENDING OF THE PLATE PRIOR TO FIXATION. THE SURGEON ELECTED TO REMOVE THE PROBLEMATIC SCREW FROM THE BONE AND DID NOT RE-USE THAT HOLE ON THE PLATE. HE REMOVED SEVERAL OTHER SCREWS TO ALLOW ACCESS TO REMOVE THE SCREW WHICH WENT THROUGH THE PLATE. HE THEN REFIXED THE PLATE BY EXCHANGING SOME BONE SCREWS FOR LOCKING SCREWS TO ACHIEVE ADEQUATE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCANEUS STANDARD PLATE, MEDIUM IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK