BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI CANCELLOUS POLYAXIAL SCREW 36MM FOR 4.0MM RODS

    MDR report key: 2875059 · Received December 17, 2012

    Report

    Report Number
    2530088-2012-01107
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 19, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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.

    Description of Event or Problem · 1

    PATIENT WAS DIAGNOSED WITH A THORACIC TUMOR AND WAS IMPLANTED WITH A ROD AND SCREW CONSTRUCT ON (B)(6) 2012, ON BOTH THE RIGHT AND LEFT SIDES. THE PATIENT RETURNED FOR A FOLLOW UP VISIT ON AN UNKNOWN DATE. AT THIS TIME, THE POST-OP X-RAYS AND A CAT SCAN REVEALED THAT THE SCREWS WERE POSITIONED INCORRECTLY. THE PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND THE SURGEON PERFORMED THE THORACIC TUMOR REMOVAL FUSION REVISION TO RE-POSITION THE RODS AND SCREWS ON THE LEFT SIDE. THE SURGEON DID NOT DO ANYTHING WITH THE RIGHT SIDE. THERE WAS NO PATIENT PAIN OR INFECTION NOTED. NONE OF THE IMPLANTS WERE BROKEN. THE SURGEON PERFORMED THE REVISION PROCEDURE SUCCESSFULLY. THIS IS 5 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM TI CANCELLOUS POLYAXIAL SCREW 36MM FOR 4.0MM RODS SCREW NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCREWS, RODS