BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFS SPINAL FIXATION SYSTEM

    MDR report key: 6483750 · Received April 11, 2017

    Report

    Report Number
    2183449-2017-00013
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    February 16, 2017
    Report Date
    April 11, 2017
    Manufacturer
    ORTHOFIX INC
    Product Code
    MNH
    PMA / PMN Number
    K994217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN THE CASE: 56-3650 6.5 MM X 50 MM MULTI-AXIAL SCREW, LOT A19, (B)(4), MFG DATE: 09/14/2012, 56-3740 7.5 MM X 40 MM MULTI-AXIAL SCREW, LOT A16, (B)(4), MFG DATE: 09/17/2012.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING THE CASE THE PRESSURE CAPS ON TWO (2) MULTI-AXIAL SCREWS (56-3650, 56-3740) ROTATED RESULTING IN A DELAY IN THE CASE. SURGEON REMOVED THE SCREWS AND BACKUP PRODUCT WAS IMMEDIATELY AVAILABLE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266063 SFS SPINAL FIXATION SYSTEM MULTI-AXIAL SCREW MNH ORTHOFIX INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR