BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES PEDICLE FINDER

    MDR report key: 11991412 · Received June 11, 2021

    Report

    Report Number
    MW5101850
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 9, 2021
    Manufacturer
    SYNTHES USA PRODUCTS, LLC
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SYNTHES/BRAINLAB PEDICLE FINDER BROKE WHILE IN USE. BOTH PIECES RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877512 SYNTHES PEDICLE FINDER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO SYNTHES USA PRODUCTS, LLC 2797.02.030N GM5378309
    877513 PEDICLE FINDER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BRAINLAB AG

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR