BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-01724

    MDR report key: 3023740 · Received March 27, 2013

    Report

    Report Number
    2520274-2013-01724
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    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. PATIENT WAS IMPLANTED WITH A TOTAL OF THREE SCREWS, 04.613.716 X 1 - 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/FIXED ANGLE 16MM AND 04.613.516 X 2 - 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM LT. IT IS UNKNOWN WHICH SCREW WAS THE ONE THAT BACKED OUT.

    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 REPORT IS FOR THE UNKNOWN SCREW THAT BACKED OUT. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126113 KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1