BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2852062 · Received November 30, 2012

    Report

    Report Number
    2520274-2012-03450
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE COMPLAINT DESCRIPTION INDICATES A NON UNION AT L4-L5 WHICH MAY HAVE SUBJECTED THE RODS TO EXCESSIVE LOADS AND/OR MOTION CYCLES. ADDITIONALLY, MARKS ON THE RODS MAY HAVE CREATED STRESS RISERS IN THE AREA OF THE BREAKAGE. BASED ON THE DESCRIPTION IT IS UNCLEAR WHAT CAUSED THE COLLAR TO BREAK. SIGNIFICANT LATERAL FORCES COMBINED WITH IMPACTION; OVER TORQUE ON THE NUTS ARE POSSIBLE. THE CAUSE OF THE DEVICE FAILURE IS UNKNOWN.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH USS CONSTRUCT AT T9-ILIUM ON (B)(6) 2011 FOR A POSTERIOR FUSION. REPORTEDLY PATIENT WAS FOUND TO HAVE BILATERAL BROKEN RODS AND NON UNION AT L4-L5. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. IT WAS NOTED INTRAOPERATIVELY THAT THE COLLAR ON THE LEFT ILIAC SCREW WAS BROKEN IN TWO PIECES. SURGEON REMOVED ALL HARDWARE AND PATIENT WAS REVISED TO DUAL-OPENING USS CONSTRUCT. THIS IS 3 OF 15 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SCREWS, NUTS, COLLARS, RODS