BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL ADJUSTABLE ROD 3.5 X 220MM - 72MM

    MDR report key: 12815075 · Received November 15, 2021

    Report

    Report Number
    1526439-2021-02405
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Report Date
    October 22, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNI
    UDI-DI
    10705034159058
    PMA / PMN Number
    K190895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PROCODE: KWP, NKG. THE DEVICE WAS 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, THE RODS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT A THIRD PARTY SERVICER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL ADJUSTABLE ROD 3.5 X 220MM - 72MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707379 MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL ADJUSTABLE ROD 3.5 X 220MM - 72MM ORTHOSIS, SPINAL PEDICLE FIXATION MNI MEDOS INTERNATIONAL SàRL CH 188364150 7418N 10705034159058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ROD, 300 MM| VIPER2 LORD. ROD120MM, COCR