BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3473154 · Received November 15, 2013

    Report

    Report Number
    1030489-2013-04548
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    October 6, 2008
    Report Date
    February 28, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 6900240, 6945828, 6955924 AND 6955926 AND 510K # K043020 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G6900240 / LOT: UNKNOWN (X2) PART: G6945828 / LOT: UNKNOWN (X2) PART: G6945924 / LOT: UNKNOWN PART: G6945926 / LOT: UNKNOWN (X2) ALTHOUGH IT IS UNKNOWN WHICH, IF ANY, OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 6955828, 6955924, 6955926 AND 6900240 WITH 510K # K043020 AND K123906 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G6945828 / LOT: UNKNOWN (X2) PART: G6945924 / LOT: UNKNOWN PART: G6945926 / LOT: UNKNOWN (X2) PART: G6900240 / LOT: UNKNOWN (X2). ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A FUSION AND LAMINOPLASTY PROCEDURE AT C4-C6. DURING THE ONE WEEK POST-OP FOLLOW UP EXAMINATION, ONE OF THE IMPLANTS HAD REPORTEDLY MIGRATED. THE PATIENT WAS DISCHARGED WITHOUT ADDITIONAL INTERVENTION BECAUSE CERVICAL INSTABILITY AND MAJOR CLINICAL SYMPTOMS WERE NOT OBSERVED. THE IMPLANT WAS RE-EXAMINED 11MONTHS POST-OP VIA CT SCAN AND WAS DOCUMENTED AS "NORMAL" AND AGAIN 29 MONTHS POST-OPERATIVELY VIA X-RAY EXAMINATION. ACCORDING TO THE REPORT, THE PATIENT HAD FUSED BY THE 29 MONTH POST-OP VISIT. NO EXPLANT WAS PERFORMED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594591 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR BONE GRAFT, RODS, SCREWS