BEUDAMED
    FDA Adverse Event Other Summary report: N

    BONE SCREWS, CROSS-PIN, 2.7X12MM,1/P

    MDR report key: 2011751 · Received March 3, 2011

    Report

    Report Number
    8010177-2011-00060
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE AND POSSIBLE ROOT CAUSES INDICATED THE ISSUE WAS WITHIN TOLERANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "AS THE SURGEON WAS PUTTING IN THE BONE SCREW, THE HEAD OF THE SCREW STRIPPED BEFORE TOUCHING THE PLATE. THE SURGEON WAS NOT ABLE TO ADVANCE THE SCREW ANY FURTHER OR BACK OUT THE SCREW. HAD TO REMOVE THE SCREW WITH EXTRACTION SET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, 2.7X12MM,1/P IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK