BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 4152187 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03922
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 27, 2014
    Report Date
    December 9, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    K052747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT MACROSCOPIC AND OPTICAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVES DID NOT IDENTIFY ANY BREAKAGE OR CRACKING. VISUAL AND OPTICAL INSPECTION NOTED MULTIPLE WITNESS MARKS IN THE MAS RETENTION AREA. SURGICAL TECHNIQUE FOR THIS PART IS FOR THE SURGEON TO REMOVE THE EXTENDER FROM THE BODY AND SCREW BY ROCKING THE EXTENDER IN A MEDI AL/LATERAL DIRECTION AND PULLING UPWARD. THIS CAN CREATE STRESSES ON THE PART THAT CAN BEND THE TIPS IF PERFORMED AGGRESSIVELY. WITNESS MARKS ON THE UPPER WALLS AND THE BENT TIP CONDITION OF THE INNER SLEEVE OF THE EVALUATED PRODUCT SUGGEST THAT AGGRESSIVE RELEASE TECHNIQUES MAY HAVE BEEN UTILIZED. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD, RESULTING IN THE FOREGOING EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCANTANEOUS FIXATION PROCEDURE FOR A TUMOR AT T11-L5. DURING THE PROCEDURE, IT WAS FOUND THAT "THE INNER SLEEVE DID NOT HOLD THE SCREW WHEN REDUCED TO THE LD POSITION. UPON INSPECTION, THE JAWS OF THE INNER SLEEVE APPEARED TO BE SLIGHTLY BENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630521 APPLIANCE, FIXATION, SPINAL INTERLAMINAL ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC FA12E036

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR