BEUDAMED
    FDA Adverse Event Summary report: N

    STIMULATOR, NERVE

    MDR report key: 2072649 · Received April 29, 2011

    Report

    Report Number
    1030489-2011-00464
    Date Received
    April 29, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 30, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    ETN
    PMA / PMN Number
    K031003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, BIOCOMPATIBILITY EVALUATIONS ON THE MATERIAL, ALONG WITH THE SMALL SIZE, SUPPORT THE BIOSAFETY OF THE MATERIAL THAT REMAINED IN THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL MACROSCOPIC EXAMINATION FOUND APPROXIMATELY 23MM OF RILSAN COATING REMOVED FROM THE TIP OF THE PEDICLE NEEDLE. THE SHAFT WAS BOWED; A BEND WAS NOTED AT THE LOWER PORTION OF THE PEDICLE NEEDLE. THE BEND WAS DETERMINED TO BE ~1 DEGREE AND WITHIN SPECIFICATION. WITNESS MARKS AND GOUGING ON THE SURFACE OF THE RILSAN COATING SUGGEST THE NEEDLE MAY HAVE BEEN SUBJECTED TO INTRAOPERATIVE BEND STRESS AND/OR TWISTING. DIMENSIONAL INSPECTION OF THE UPPER PORTION OF THE INSTRUMENT SHAFT FOUND THE SHAFT OUTER DIAMETER (INCLUDING COATING) WITHIN PRINT SPECIFICATION (0.178). MINIMAL AND ISOLATED AREAS OF DISCOLORATION WERE IDENTIFIED ON THE INSTRUMENT SHAFT WHERE THE RILSAN COATING HAD BEEN REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE SURGEON TAPPED THE PAK NEEDLE INTO THE SACRUM AND A 1/4 TO 1/2 INCH OF THE INSULATION PEELED OFF DURING THE POSTERIOR LUMBAR INTERBODY FUSION (PLIF) PROCEDURE. THE INSULATION WAS NOT ABLE TO BE REMOVED AND REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULATOR, NERVE ETN WARSAW ORTHOPEDIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR