BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 10033427 · Received May 7, 2020

    Report

    Report Number
    1030489-2020-00509
    Event Type
    Injury
    Date Received
    May 7, 2020
    Report Date
    May 7, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6950315, 510K # K052734 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PSEUDO-TUMOR; AND UNDERWENT CERVICAL POSTERIOR FIXATION FROM OCCIPITAL TO C4. ON AN UNKNOWN DATE, POST-OP, THE ALLEGED SET SCREW LOOSENED, LEADING TO BACKING-OUT OF THE ROD ON THE CAUDAL SIDE OF OCCIPITO-CERVICAL (OC) PLATE. THE ROD WAS FOUND TO HAVE COME OFF FROM UNDER THE RIGHT OCCIPITAL PLATE. IT WAS CONSIDERED THAT SINCE A CROSSLINK HAD NOT BEEN USED, THE SET SCREW LOOSENED DUE TO THE MOVEMENT OF ROTATION, AND THE ROD CAME OFF. THE SURGEON ALSO SUSPECTED THAT SINCE THE PROTRUDING PART OF THE ROD FROM THE CONNECTION PART WITH OC PLATE WAS NOT LONG ENOUGH, THE ROD COULD HAVE COME OFF DUE TO ROTATION. NO PROBLEM SUCH AS BREAKAGE WAS FOUND IN THE SET SCREW. THERE WAS A PROLONGATION OF HOSPITALIZATION AS A RESULT OF ROD BACK-OUT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020, WHICH WAS COMPLETED WITHOUT ANY PROBLEMS. THE EXPLANTED SET SCREW WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495535 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ROD