BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA-ONE PLATE 2 LEVEL/32MM

    MDR report key: 3023754 · Received March 27, 2013

    Report

    Report Number
    8030965-2013-01155
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K071667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH VECTRA PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. POST-OPERATIVE X-RAYS TAKEN ON AN UNKNOWN DATE SHOWED THAT THE TOP SCREW HAD BACKED OUT. PATIENT DID NOT PRESENT PAIN. NO REVISION SURGERY HAS BEEN PLANNED AT THIS TIME. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125965 TI VECTRA-ONE PLATE 2 LEVEL/32MM KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1