BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST360 SCREWS

    MDR report key: 2971857 · Received February 19, 2013

    Report

    Report Number
    2184052-2013-00011
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 4.5 YEARS POST-OPERATIVELY, THREE SCREWS BROKE AFTER A PATIENT EXPERIENCED A FALL. THE INDEX PROCEDURE TOOK PLACE APPROXIMATELY 7 YEARS AGO. AT THAT TIME L2-L4 WERE TREATED USING AN ST360 CONSTRUCT. APPROXIMATELY 3 YEARS POST-OPERATIVE OF THE INDEX SURGERY, THE PATIENT PRESENTED WITH LOW BACK PAIN AND RADICULOPATHY TO THE HIPS; PARS FRACTURE IDENTIFIED AT THE RIGHT L5. THE ENTIRE CONSTRUCT WAS REMOVED WITH THE EXCEPTION OF THE SCREW AT THE LEFT L4. NEW ST360 INSTRUMENTATION WAS IMPLANTED AT L4-S1 WITH ALLOGRAFT USED AS AN INTERBODY. APPROXIMATELY 4.5 YEARS POST-OPERATIVELY THE SECOND SURGERY, THE PATIENT EXPERIENCED A FALL. IT WAS FOUND THAT THE PATIENT HAD NOT FUSED AND THAT THREE SCREWS BROKE (LEFT S1 AND L4 BILATERAL). THE SCREWS BROKE MID-SHAFT AND THE SHANKS WERE LEFT IN THE PATIENT. ALL OTHER INSTRUMENTATION WAS REMOVED AND NON-ZIMMER HARDWARE WAS USED TO REPLACE AT L3-S1 BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72415 ST360 SCREWS ST360 SCREWS KWQ ZIMMER SPINE 07.00319.022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention