BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE

    MDR report key: 2863957 · Received December 10, 2012

    Report

    Report Number
    2520274-2012-03739
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR CATALOG NUMBER OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    DURING SURGERY FOR A DISTAL RADIUS FRACTURE USING A FOUR-HOLE DISTAL RADIUS PLATE, THE LOCKING SCREW DID NOT LOCK. SURGEON MAY HAVE TURNED IT WIDE BUT WITHIN 15 DEGREES ALLOWING IN THE SLEEVE. THE PLATE OR THE SCREW MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS THE 2ND OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW