BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE X25 INSERTER/TIGHTENER

    MDR report key: 8842723 · Received July 30, 2019

    Report

    Report Number
    1526439-2019-51901
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWR
    UDI-DI
    10705034467634
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). UDI: (B)(4). DEVICE INITIALLY REPORTED AS A MALFUNCTION. DEVICE WAS RETURNED FOR EVALUATION AND THE OBSERVED DAMAGE OF STRIPPING DOES NOT CONSTITUTE A REPORTABLE EVENT. AS SUCH, THIS EVENT IS NOW CONSIDERED TO BE A NON-REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    THE SCREW DRIVER BROKE WHILE TIGHTENING THE SET SCREW. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637577 VERSE X25 INSERTER/TIGHTENER DRIVER, PROSTHESIS HWR MEDOS INTERNATIONAL SàRL CH 299704230 GM5160604 10705034467634

    Patients

    Seq Age Sex Outcome Treatment
    1