BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE RETRACTOR-CENTER/LONG

    MDR report key: 2994051 · Received February 27, 2013

    Report

    Report Number
    1719045-2013-10187
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. UPON RECEIVED OF THE DEVICE, ALL FUNCTIONAL TESTING WAS PERFORMED SUCCESSFULLY, THE GAGE EASILY SNAPPED INTO PLACE AND WAS EASILY REMOVED. THE INSTRUMENT CONFORMED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE MINIMALLY INVASIVE LUMBAR FUSION PROCEDURE AT LEVELS L4-S1, THE TISSUE RETRACTOR (0.616.037) STUCK TO THE SCREW. IN THE PROCESS OF THE RETRACTOR REMOVAL, THE DEVICE DID NOT COME OUT EASILY, BUT GOT STUCK IN THE SCREW. FINALLY SURGEON WAS ABLE TO REMOVE THE DEVICE AND SUCCESSFULLY COMPLETE THE PROCEDURE. THIS EVENT ADDED ABOUT 35 MINUTES TO THE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84168 TISSUE RETRACTOR-CENTER/LONG GAD SYNTHES (USA) MONUMENT 6501709

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention