BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CURVED ROD 80MM

    MDR report key: 11112066 · Received January 4, 2021

    Report

    Report Number
    2939274-2021-00017
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Report Date
    December 7, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MNH
    UDI-DI
    10705034788982
    PMA / PMN Number
    K142838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICES WERE ACTUALLY REMNANTS OF IMPLANTS WHICH WERE CUT DURING THE SURGERY AND NOT BROKEN AS ORIGINALLY REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: KWP, MNI, NKG. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON (B)(6) 2020, ONE (1) 4.0MM TI CURVED ROD AND ONE (1) 3.5MM TI CURVED ROD WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) 3.5MM TI CURVED ROD 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9744 3.5MM TI CURVED ROD 80MM ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 498.137 3404947 10705034788982

    Patients

    Seq Age Sex Outcome Treatment
    1