BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANCELLOUS POLYAXIAL

    MDR report key: 1922112 · Received December 7, 2010

    Report

    Report Number
    2530088-2010-00227
    Event Type
    Injury
    Date Received
    December 7, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    PMA / PMN Number
    K070573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW WILL BE REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST CONSTRUCT IMPLANTATION, C3 TO S1 RETURNED TO SURGEON AFTER A FALL. AN X-RAY SHOWED THREE CANCELLOUS POLYAXIAL SCREWS. DURING THE REVISION THE SURGEON REMOVED THE BROKEN TOP PORTION OF THE THREE SCREWS AND LEFT THE REMAINING SHAFTS IN PATIENT'S BONE. SURGEON REVISED THE PT FROM C2 TO T2 WITH ANOTHER CONSTRUCT. THIS IS THREE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI CANCELLOUS POLYAXIAL CANCELLOUS POLYANIAL SCREW MNI SYNTHES BRANDYWINE NA 5603118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD