BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6636010 · Received June 13, 2017

    Report

    Report Number
    1030489-2017-01532
    Event Type
    Injury
    Date Received
    June 13, 2017
    Report Date
    May 16, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PRODUCTS WERE IMPLANTED INCLUDING: PRODUCT ID: 7750508, LOT # UNK, QTY: 3, UDI (B)(4), 510K: K071942; 7750510, UNK, 1, (B)(4), K071942. THE QUANTITY OF OCCIPITAL SCREWS THAT LOOSENED IS UNKNOWN. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH CERVICAL MYELOPATHY UNDERWENT POSTERIOR CERVICAL ARTHRODESIS AT C1-C2 AND OCCIPITAL. POST-OP, AFTER FEW DAYS OF THE SURGERY, THE OCCIPITAL SCREWS LOOSENED UP. THE PATIENT WILL BE RE-OPERATED NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418292 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention