BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS SINGLE INNER SETSCW

    MDR report key: 8935265 · Received August 27, 2019

    Report

    Report Number
    1526439-2019-52040
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    July 8, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034121192
    PMA / PMN Number
    K160904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL: 1867-15-000, LOT 152663 SET SCREW RETURNED WITH NO PROBLEMS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE 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

    (B)(6). MADE AWARE - 8/7/19. PRESENT IN THEATRE - YES. DELAY IN PROCEDURE - APPROX 5-10MIN. IMPACT TO PATIENT - NONE. PRODUCT CODE (1)- 179712600 LOT GM4196503. PRODUCT CODE (2) - 179702000S QTY = 4, LOT = UNKNOWN. AM I IN POSSESSION - AWAITING STERILISATION. WHAT HAPPENED - POINT OF TORQUE WRENCH SHAFT WAS SPINNING IN SET SCREW HEAD, WE HAD TO CHANGE TO ALTERNATIVE INSTRUMENTS. EVIDENCE OF WEAR AT HEX OF SHAFT. 4 SET SCREWS STRIPPED OUT LEAVING SHARP METAL DEBRIS. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731859 MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 186715000 152663 10705034121192

    Patients

    Seq Age Sex Outcome Treatment
    1