BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7103578 · Received December 11, 2017

    Report

    Report Number
    1030489-2017-02480
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    November 15, 2017
    Report Date
    February 27, 2018
    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

    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 # H5303886 AND LOT # H5326013. 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. MANUFACTURE DATE FOR LOT H5303886 IS 06 OCT 2016; MANUFACTURE DATE FOR LOT H5326013 IS 10 JAN 2017; PRODUCT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION WERE PERFORMED. 13 PIECES OF THE CONSTRUCT WERE RETURNED. THE SCREW THAT HAD BACKED OUT WAS EASILY IDENTIFIED AS THERE WAS A STARBURST WEAR PATTERN TO THE FACE OF THE SCREW FROM THE ROD MOVING BACK AND FORTH ON THE SCREW AS IT BACKED OUT (PART# G6950315;LOT# H5303886). THERE DOES APPEAR TO BE SOME WITNESS MARKS ON THE EDGE OF THE SCREW INDICATING THAT THE ROD MAY HAVE BEEN OVER ANGULATED OR NOT FULLY SEATED IN THE PLATE WHEN THE SET SCREW WAS INSTALLED. THIS, HOWEVER, CAN NOT BE FULLY CONFIRMED DUE TO THE AMOUNT OF DAMAGE TO THE SCREW FACE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT PRE-OPERATIVELY DIAGNOSED WITH CERVICAL DISLOCATION UNDERWENT OCCIPITAL FIXATION. POST -OP, THE ROD GOT DETACHED FROM THE OC PLATE BECAUSE ONE OF THE SET SCREWS PLACED AT OCCIPITAL BONE PLATE OF RIGHT SIDE WAS BACKED OUT COMPLETELY. RE-OPERATION WAS PERFORMED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886345 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD, SCREWS, PLATE