BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANCELLOUS POLYAXIAL

    MDR report key: 1982279 · Received February 1, 2011

    Report

    Report Number
    2530088-2011-00018
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, A DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED. 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 A DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    PT STATUS POST ANTERIOR VASCULARIZED FIBULA STRUT GRAFT WITH POSTERIOR SCREW PLACEMENTS IN THE T10 TO L5 REGION AND POSTERIOR L1 TO L4 FUSION RETURNED TO SURGEON FOR POST OP VISIT. AN X-RAY SHOWED TWO SCREWS BROKEN AT L5. SURGEON REMOVED THE ENTIRE CONSTRUCT AND DID NOT REVISE THE PT TO ANYTHING NOTING THE BONES WERE FUSED. SURGEON ALSO NOTED THE PT WAS NOT PUT INTO A BACK BRACE AFTER IMPLANTATION. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI CANCELLOUS POLYAXIAL CANCELLOUS POLYAXIAL SCREWS MNI SYNTHES BRANDYWINE NA 6239589

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention ALLOGRAFT| ROD