BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 TI CORT FIX 6X50MM

    MDR report key: 9805847 · Received March 9, 2020

    Report

    Report Number
    1526439-2020-00666
    Event Type
    Injury
    Date Received
    March 9, 2020
    Report Date
    February 10, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    UDI-DI
    10705034351841
    PMA / PMN Number
    K110216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON PERFORMED A REVISION OF CONCORDE LIFT CAGE AND A BROKEN CORTICAL FIX SCREW. THE SURGEON REPLACED THE CAGE AND LEFT THE REMAINING SCREW SHANK IN THE PATIENT AFTER CONFIRMING IT WAS FULLY BURIED IN THE BODY OF L3. THEY BELIEVE THE CAGE LOST SOME HEIGHT AND FAILED TO FUSE. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: CONCORDE LIFT, CONVEX 9X21 (PART#: 197809021C, LOT#: 203128, QUANTITY#: 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268846 5.5 TI CORT FIX 6X50MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH 186731650 218438 10705034351841

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention