BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI QUICK LOCK CANCELLOUS SCREW

    MDR report key: 2062705 · Received April 12, 2011

    Report

    Report Number
    1719045-2011-00178
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    K971883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT EXPLANTED. UNABLE TO PROVIDE THE DATE OF MFR, NO LOT NUMBER PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST PLATE AND SCREW IMPLANTATION RETURNED TO OFFICE FOR POST OP VISIT. AN X-RAY SHOWED A QUICK LOCK CANCELLOUS SCREW PULLED OUT AT C6 IN THE TI CERVICAL SPINE LOCKING PLATE. SURGEON NOTED THE PT WAS HEALED. SURGEON IS NOT REMOVING THE HARDWARE. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM TI QUICK LOCK CANCELLOUS SCREW QUICK LOCK CANCELLOUS SCREW KWQ SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE