BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1772416 · Received July 23, 2010

    Report

    Report Number
    1030489-2010-00962
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 23, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    MNI
    PMA / PMN Number
    K984522
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (PSEUDOARTHROSIS): THE DEVICE WAS RETURNED FOR EVAL. MACROSCOPIC EXAM CONFIRMS THE BONE SCREW IS BROKEN; MICROSCOPIC EXAM REVEALS A FAIRLY FLAT FRACTURE SURFACE WITH PROGRESSIVE STRIATIONS, INDICATIVE OF FATIGUE. LOWER PORTION OF BONE SCREW REVEALS EXTENSIVE SURFACE DAMAGE, TYPICAL OF SURGICAL EXTRACTION FROM BONE, POSSIBLY UTILIZING TREPHINE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SINGLE LEVEL POSTERIOR LATERAL FUSION AT L2-3. SOMETIME POST OP, IT WAS DISCOVERED THAT A SCREW WAS BROKEN. A REVISION WAS DONE DUE TO PSEUDOARTHROSIS AND TO REMOVE THE BROKEN SCREW. NO FURTHER PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM BONE SCREW MNI WARSAW ORTHOPEDIC INC NA W05G3996

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BONE SCREWS| IMPLANT| EXPLANT| RODS| IMPLANT| EXPLANT| IMPLANT| IMPLANT| EXPLANT| SET SCREWS| EXPLANT| CONNECTORS| IMPLANT| CROSSLINK| EXPLANT