BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3645424 · Received February 25, 2014

    Report

    Report Number
    1030489-2014-00567
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6950315, 510K # K042498 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

    SET SCREW LOCATION WITHIN CONSTRUCT UNKNOWN. SET SCREW THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE MORPHOLOGY IS FOUND TO BE FAIRLY TALL AND FLAT, WHICH IS ATYPICAL OF FULL TIGHTENING. FULLY TIGHTENED SET SCREWS NODES ARE TYPICALLY TROUGHED OR CONCAVE AFTER FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) SIGNIFICANTLY DIFFERENT THAN TYPICAL FROM BENCH TESTED SAMPLES. ADDITIONALLY, THE ABSENCE OF ROD WITNESS MARKS ON EITHER SIDE OF THE SET SCREW NODE IS CONSISTENT WITH THE ROD NOT FULLY SEATED IN THE MAS SADDLE AT FINAL TIGHTENING. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE RODE MAY NOT HAVE BEEN COMPLETELY SEATED IN MAS AT FINAL TIGHTENING.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # H13T0535, # H13J2176 AND # H13J0694. MANUFACTURE DATE FOR LOT H13J0694 IS 9/10/2013; MANUFACTURE DATE FOR LOT H13J2176 IS 9/20/2013; MANUFACTURE DATE FOR LOT H13T0535 IS 8/06/2013.

    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
    115950 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

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