BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

    MDR report key: 7018996 · Received November 10, 2017

    Report

    Report Number
    1030489-2017-02306
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 13, 2017
    Report Date
    November 10, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    K150135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHICH OF THE TWO DEVICES LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART# , LOT# , QTY , UPN: 2150135, 0446204W , 1 , (B)(4); 2150125, 0403865W , 1 , (B)(4); 2150130 , 0537413W, 2 , (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OP, TWO SCREWS IMPLANTED AT S1 BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. NO REVISION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798333 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR