BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2822932 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02901
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: ON THE OR REPORT, THERE IS A LINE ITEM, DEVICE DESCRIPTION RECORDED AS A PLATE; PART NUMBER 449.931 X2. THIS IS MOST LIKELY AN ERROR AND THE PART NUMBER SHOULD BE 499.931, A SCREW, THAT WOULD LIKELY BE ASSOCIATED WITH THIS CONSTRUCT. UNTIL CLARIFICATION AND ADDITIONAL INFORMATION HAS BEEN RECEIVED, 2 SCREWS HAVE BEEN REPORTED AS UNKNOWN. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR CATALOG NUMBER OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT HAD A TLIF PROCEDURE ON (B)(6) 2010 AND WAS IMPLANTED WITH 4 SCREWS, 2 RODS AT L 3-4, 4-5. POST-OPERATIVELY, THE PATIENT EXPERIENCED NON-HEALING OF THE SURGICAL INCISION SITE. EXERTION RESULTS IN OPENING AND BLEEDING AT THE SITE. THE PATIENT HAS UNDERGONE EXTENSIVE TESTING AND NO INFECTION WAS FOUND. ALLERGY TESTING WAS DONE AND IS POSITIVE FOR METALS. THERE IS NO PLAN FOR REVISION AT THIS TIME. THIS IS THE # 6 OF 6 OF REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, RODS