BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METRX

    MDR report key: 3811365 · Received May 15, 2014

    Report

    Report Number
    1030489-2014-02521
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. (B)(4): ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CATALOG NUMBER 9560420 (DILATOR) WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. CONCOMITANT PRODUCTS (STABILITY PINS) 9569310 X 2 WERE RETURNED FOR EVALUATION EVALUATION OF THE STABILITY PINS DID NOT REVEAL ANY DAMAGE TO THE INSTRUMENTS. BASED ON THE EVENT DESCRIPTION, IT APPEARS THE EVENT WAS RELATED TO THE SURGICAL TECHNIQUE. NO PRODUCT PROBLEM WAS OBSERVED.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT AN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) WITH PEDICLE SCREW FIXATION AT L4-L5. THE FOLLOWING DAY, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND AN MRI EXAMINATION REVEALED AN URETERAL INJURY. THUS, THE PATIENT UNDERWENT AN EMERGENCY URETERAL RECONSTRUCTION SURGERY. NO INTRAOPERATIVE COMPLICATION AS WELL AS MALFUNCTION OF IMPLANTS OR INSTRUMENTS OCCURRED. IN THE REVISION SURGERY, ONLY LEFT URETERAL RECONSTRUCTION WAS CONDUCTED. ALSO, IT WAS REPORTED THAT AT THE TIME FIXING THE BLADE INTRAOPERATIVELY, BLADE PIN(S) WERE PLACED ANTERIORLY AND THAT CAUSED INSUFFICIENT FIXATION. THUS, BLADE PINS WERE REMOVED ONCE AND THEN INSERTED AGAIN INTO APPROPRIATE POSITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290424 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MSD BARTLETT MFG NA BA05G002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PEDICLE SCREWS, BLADES, BLADE PINS