BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3645402 · Received February 25, 2014

    Report

    Report Number
    1030489-2014-00568
    Event Type
    Injury
    Date Received
    February 25, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOOSE SCREW. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6958716, 510K # K081297 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: VERTEX CONSTRUCT IS NOTED C2 PEDICLE SCREWS, SPANNING C3 THEN LATERAL MASS SCREWS AT C4, C5, PEDICLE SCREWS WITH LATERAL CONNECTORS NOTED AT C6 AND C7. SET SCREW HAS BACKED OFF ALLOWING THE ROD TO DISSOCIATE FROM THE C2 SCREW.

    Additional Manufacturer Narrative · 1

    MAS HEAD THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. MAS CROWN WITNESS MARKS SUGGEST AN INCOMPLETELY SEATED/ANGULATED ROD, WITH ONE CROWN WITH FULL AND SYMMETRICAL ROD MARKS THAT ARE CONSISTENT WITH FULL SEATING, AND TWO WITH PARTIAL SEATING, AS EVIDENCED BY THE SYMMETRICAL ROD WITNESS MARKS AND ONE MAS HEAD WITH MISSING ROD MARKS ON ONE SIDE OF THE CROWN. MAS HEAD CROWN WITNESS MARKS CONSISTENT WITH INCOMPLETE SEATING OF ROD DURING FINAL TIGHTENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL CERVICAL PROCEDURE. SOMETIME POST-OP IT WAS REPORTED THAT THE SETSCREWS ARE LOOSE AND ALLOWED THE ROD TO BACK OUT AT C2 AND THE BONE SCREW WAS LOOSE AT LEFT SIDE C4 AND LEFT SIDE C5. ONE MONTH POST-OP THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE BONE SCREWS WERE REMOVED AND NEW SCREWS WERE REPLACED AND ADDITIONAL SCREWS WERE ADDED AT T1 AND T2 AS WELL AS A CROSSLINK AT C6-7. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115922 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13C2371

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention RODS, SET SCREWS