BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4/2.7MM TI VA-LCKNG OPENING WEDGE PLATE/7MM SPACER

    MDR report key: 3030064 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-00836
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE OPENING WEDGE PLATE IS INTACT AND ALSO WITHIN THEIR SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO THIS LOT. ALL PARTS PASSED SPECIFICATIONS. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS REPORT IS #4 OF 4 FOR THE SAME EVENT REPORTED UNDER COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN THE (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH PLATE AND VA LOCKING SCREWS FOR HALLUX VALGUS ON AN UNKNOWN DATE. IT WAS NOTED: EARLY FULL WEIGHT BEARING DONE BY THE PATIENT LED TO A BROKEN 2.4MM VA LOCKING SCREW. PATIENT WAS RETURNED TO THE OR, DATE UNKNOWN, AND SURGEON REMOVED THE BROKEN HARDWARE SUCCESSFULLY. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134672 2.4/2.7MM TI VA-LCKNG OPENING WEDGE PLATE/7MM SPACER HRS SYNTHES MONUMENT 6676250

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention