BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW LOCKING

    MDR report key: 2926037 · Received January 23, 2013

    Report

    Report Number
    2520274-2013-00542
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND 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

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE OPERATION WAS PERFORMED FOR THE PURPOSE OF THE RE ASSESSMENT OF A LUMBAR DEGENERATIVE SPONDYLOLISTHESIS. DURING THE INSERTION OF THE SETSCREW INTO PEDICLE SCREW MATRIX BY USING A PERSUADER, THE SETSCREW WAS STOPPED AROUND THE FIRST THREAD. THE NEW SETSCREW PACK WAS OPENED AND THE DOCTOR TRIED TO INSERT; THE NEW SETSCREW COULD NOT BE INSERTED. SURGEON REMOVED THE PEDICLE SCREW, SELECTED ANOTHER SCREW AND COMPLETED THE PROCEDURE. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31785 SCREW LOCKING HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR PEDICLE SCREW, LOCKING SCREW, LOCKING CAP