BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE RODS GENERIC

    MDR report key: 3062935 · Received April 12, 2013

    Report

    Report Number
    2184052-2013-00017
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    July 1, 2012
    Report Date
    March 14, 2013
    Manufacturer
    ZIMMER SPINE
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNK AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS EXCESSIVE STRESS TO THE IMPLANT AS A RESULT OF A MOTOR VEHICLE ACCIDENT. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVE ROD BREAKAGE OCCURRED. PT UNDERWENT SPINAL FIXATION USING SILHOUETTE INSTRUMENTATION IN (B)(6) 1999. IN (B)(6) 2012, THE PT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT IN WHICH SHE WAS REAR-ENDED. X-RAYS TAKEN AFTER THE ACCIDENT REVEALED THE ROD ON THE RIGHT SIDE OF THE CONSTRUCT WAS BROKEN IN THE MIDDLE. THE PT UNDERWENT REVISION SURGERY IN (B)(6) 2013, AT WHICH TIME ADJACENT LEVEL DECOMPRESSION WAS PERFORMED AND THE CONSTRUCT WAS REMOVED WITH NO NEW INSTRUMENTATION ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157808 SILHOUETTE RODS GENERIC SILHOUETTE RODS GENERIC MCV ZIMMER SPINE SILHOUETTE RODS GENERIC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R