BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTEX SCREW S.T. ?2.7X28MM

    MDR report key: 1775910 · Received July 22, 2010

    Report

    Report Number
    8031020-2010-00087
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K972323
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PT AS MDR 8031020-2010-00086, MDR 8031020-2010-000878, MDR 8031020-2010-00089, MDR 8031020-2010-00090.

    Description of Event or Problem · 1

    DURING SPS SMALL SURGERY, THE SURGEON DID NOT NOTICE THAT THE STERILIZATION TIME FOR THE SCREWS HAD EXCEEDED. FIVE SCREWS WERE IMPLANTED. THE STERILIZATION TIME LIMIT FOR FOUR SCREWS WAS (B)(6) 2010 AND THE STERILIZATION TIME LIMIT OF ONE SCREW WAS (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTEX SCREW S.T. ?2.7X28MM IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA K09725

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other