BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3630817 · Received February 17, 2014

    Report

    Report Number
    1030489-2014-00491
    Event Type
    Injury
    Date Received
    February 17, 2014
    Date of Event
    July 27, 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 6955724, 6955718, 6955720, 6955830, 7544530, 7544535 AND 6955240 WITH 510K # K042789 AND K123906 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G6945724 / LOT: UNKNOWN (X5) PART: G6945718 / LOT: UNKNOWN PART: G6945720 / LOT: UNKNOWN PART: G6945830 / LOT: UNKNOWN PART: G75444530 / LOT: UNKNOWN (X3) PART: G75444535 / LOT: UNKNOWN (X4) PART: G6955240 / 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

    THE SUSPECT DEVICE WAS NOT IDENTIFIED; THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE: G6945718, RM91; G6945720, RL56; G6945724, PY52; G6950305, 0063705W; G6950305, 0083400W; G6955240, 0053045W; G6955240, 0074800W; G6955255, 0056435W; G7540120, 0090711W; G7540120, 0090713W; G75444530, H09G9344; G75444530, W06L0389; G75444530, W08F0490; G75444535, H09G9712; G811H321, 0074791W; G6945724, PY51; G6945724, RB54J; G6945724, RM93; G7002527, 0017542W; G75444030, H09D4813. (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SPINAL SURGERY AT C2-T3 ALONG WITH A BILATERAL LAMINOPLASTY, FORAMINOTOMY AND DOME OSTEOTOMY. IT WAS REPORTED THAT 6 DAYS POST-OP RIGHT C5 PALSY AND A HEMATOMA WERE FOUND. A SURGERY WAS PERFORMED TO REMOVE THE HEMATOMA AND RE-INSERT THE SCREW AT C4. A FORAMINOTOMY BETWEEN RIGHT C4 AND C5 WAS PERFORMED THE FOLLOWING DAY. ALSO DURING THE SURGERY A LESION AT THE SURGICAL SITE WAS EXPLORED AND THE ROD WAS CUT AT C2 AND A CROSSLINK WAS ADDED. THE PATIENT COMPLAINED OF PARALYSIS OF THE RIGHT SHOULDER 6 DAYS POST-OP. THE PARALYSIS WORSENED 7 MONTHS POST-OP. A SURGERY WAS PERFORMED 7 MONTHS POST OP TO REMOVE A HEMATOMA AND A FORAMINOTOMY WAS PERFORMED. DURING THE SURGERY THE LEFT ROD WAS CUT AT C3 AND A CROSSLINK WAS ADDED. THE EVENT RESOLVED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100167 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention SCREWS, RODS, SETSCREW