BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 36MM

    MDR report key: 2971055 · Received February 21, 2013

    Report

    Report Number
    2530088-2013-00203
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWC
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTED DATE OF IMPLANT WAS IN 2008, DATE UNKNOWN. 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 IMPLANTED WITH OCCIPITAL PLATE, RODS, AND SCREWS ON AN UNKNOWN DATE IN 2008. PATIENT PRESENTED WITH PAIN AND BROKEN SPINE HARDWARE FROM A PREVIOUS FUSION. IT WAS REPORTED THE OCCIPITAL PLATE WAS CRACKED AT THE JUNCTION WHERE BOTH RODS ATTACH TO THE PLATE. ONE SCREW THAT WAS IMPLANTED IN THE LATERAL MASS ON THE RIGHT SIDE OF C2 HAD A BROKEN SHAFT JUST BELOW HEAD OF THE SCREW. THE 3.5 SYNAPSE ROD WAS ALSO BROKEN ON THE LEFT SIDE BETWEEN THE OCCIPUT AND C2. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 TO REMOVE ALL THE POSTERIOR SPINE HARDWARE. PATIENT WAS REVISED WITH LARGER SYNAPSE 4.0 SYSTEM FROM OCCIPUT TO C7. THIS IS 10 OF 12 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75406 3.5MM TI CANCELLOUS POLYAXIAL SCREW 36MM POLYAXIAL SCREW HWC SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention