BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 10400478 · Received August 13, 2020

    Report

    Report Number
    1030489-2020-01083
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 13, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958716, 510K # K081297 AND UPN 00613994355034 WAS CLEARED IN THE UNITED STATES. FOREIGN: (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT CERVICAL LUXATION FRACTURE SUGGESTED FOR SPINAL THERAPY. EVENT OCCURRED POST-OP. THERAPY: POSTERIOR FIXATION WAS PERFORMED AT C3/4/5/6/7 WITH LMS SCREW. IT WAS REPORTED THAT BACK OUT OF THE LMS SCREWS AT C6/7 WAS FOUND OUT DURING POSTOPERATIVE FOLLOW UP OBSERVATION. DEVICE STATUS: IMPLANTED. REMAINS IN PATIENT. REVISION SURGERY IS PLANNED. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. UPDATE 2020-AUG-11; IN REVISION SURGERY((B)(6) 2020) IMPLANT WAS EXPLANTED AND REPLACED. THE PRODUCT WILL NOT BE RETURNED. THE PRODUCT WAS DISCARDED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869029 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G6956416 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention