BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2960266 · Received February 14, 2013

    Report

    Report Number
    2520274-2013-00938
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 2-LEVEL VECTRA PLATE AT C5-C6, C6-C7 ON (B)(6) 2009 RETURNED TO SURGEON ON AN UNKNOWN DATE FOR FOLLOW UP VISIT. EXAM AND X-RAYS REVEALED ORIGINAL LEVELS HAD FUSED, BUT THERE WAS ADJACENT LEVEL DISEASE AT C3-C4, C4-C5, AND A LOOSE SCREW AT C7 RIGHT. PATIENT WAS RETURNED TO OR ON (B)(6) 2013, SURGEON REMOVED 1 PLATE AND 6 SCREWS FROM C5-C6, C6-C7, WITH NO HARDWARE BEING REPLACED AT THOSE LEVELS. SURGEON THEN IMPLANTED ANOTHER 2-LEVEL VECTRA PLATE AT C3-C4, C4-C5, AND COMPLETED THE PROCEDURE. THERE WAS NO FURTHER INFORMATION ON THE PATIENTS RECOVERY. THIS IS 4 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64435 SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention