BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2024019 · Received March 14, 2011

    Report

    Report Number
    2530088-2011-00054
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    February 18, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE HAS NOT BEEN EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST POSTERIOR THORACIC LUMBAR FIXATION FOR DEFORMITY ON (B)(6) 2010 RETURNED TO THE SURGEON FOR A POST OP VISIT. AN X-RAY SHOWED A TI MATRIX LOCKING CAP BACKING OUT OF A MATRIX POLYAXIAL SCREW. SURGEON IS NOT REMOVING THE HARDWARE AND IS MONITORING THE PATIENT. THIS IS TWO OF TWO COMPLAINTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI MATRIX POLYAXIAL SCREW MNI SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOCKING CAP