BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7410549 · Received April 10, 2018

    Report

    Report Number
    1030489-2018-00529
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 10, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    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 # 6958716, 510K # K081297 AND UPN (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE PRODUCT NOR THE APPLICABLE IMAGES 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 DISLOCATION FRACTURE AT C5 AND T4 UNDERWENT POSTERIOR CERVICAL SPINAL FUSION AT C5/6 AND T2/9. INTRA-OP, A SCREW WAS INSERTED AT LEFT C6. THE SCREW COULD NOT GRIP BONE FIRMLY AND THE LATERAL MASS WAS BROKEN WHEN PERFORMING RODDING. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260046 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR