BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.0MM TI USS VARIABLE AXIS SCREW 45MM THREAD LENGTH

    MDR report key: 2874632 · Received December 15, 2012

    Report

    Report Number
    2530088-2012-01093
    Event Type
    Injury
    Date Received
    December 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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 USS CONSTRUCT AT L3 - S1 ON (B)(6) 2007. SURGEON REPORTED PATIENT WAS RETURNED TO THE O.R. ON AN UNKNOWN DATE FOR REVISION. PATIENT DEVELOPED SPINAL STENOSIS ABOVE THE PREVIOUS USS FUSION. SURGEON PERFORMED A LAMINECTOMY. SURGEON DID NOT ADD OR REMOVE ANY HARDWARE. THIS IS THE PATIENTS FIRST REVISION. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR THE SECOND REVISION AND REMOVAL OF HARDWARE DUE TO PATIENT DEVELOPING SPINAL STENOSIS ABOVE THE PREVIOUS USS FUSION AT L3 - S1. THIS IS 6 OF 27 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.0MM TI USS VARIABLE AXIS SCREW 45MM THREAD LENGTH SCREW NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW, COLLAR, NUT, ROD, TRANSCONNECTOR