BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3472165 · Received November 15, 2013

    Report

    Report Number
    1030489-2013-04533
    Event Type
    Injury
    Date Received
    November 15, 2013
    Date of Event
    January 13, 2010
    Report Date
    February 28, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 6955718, 6955716, 6955720, 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: G6945718 / LOT: UNKNOWN (X2) PART: G6945816 / LOT: UNKNOWN PART: G6945720 / LOT: UNKNOWN (X3) 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.

    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, 6955710, 6955718 AND 6955716 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: G6945720 / LOT: UNKNOWN (X2) PART: G6945718 / LOT: UNKNOWN PART: G6945716 / LOT: UNKNOWN ALTHOUGH IT IS UNKNOWN WHICH, IF ANY, 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 DECOMPRESSION PROCEDURE AT C3-C7 AND ONE DAY AFTER SURGERY, THE PATIENT EXHIBITED SYMPTOMS OF C7 PALSY. THE SYMPTOMS WERE REPORTEDLY MILD AND RESOLVED 3 MONTHS AFTER DATE OF ONSET. NO TREATMENT WAS PROVIDED. ACCORDING TO THE REPORT, THE INDEX SURGERY "ACHIEVED ITS THERAPEUTIC GOAL OF STABILIZATION, BONE FUSION, DEFORMITY CORRECTION, DECOMPRESSION AND PATHOGENIC PROCESS CONTROL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592308 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK MSB_UNK_HDWR_VTX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS, SCREWS