BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFERENCE PEDICLE SCREW SYSTEM

    MDR report key: 3727270 · Received January 23, 2014

    Report

    Report Number
    3005032068-2014-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 11, 2013
    Report Date
    January 23, 2014
    Manufacturer
    AMEDICA CORP.
    Product Code
    MAX
    PMA / PMN Number
    K081296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO AMERICA FOR EVALUATION 01/07/2014. SET SCREWS AND RODS RETURNED. EXAMINATION OF THE MATING SURFACES ON THE RODS AND SET SCREWS SHOWED DEFORMATION CONSISTENT WITH TIGHTENING OF THE SCREWS. ONE OF THE RODS SHOWED THE SET SCREW WAS SET TO THE VERY END OF THE ROD. UNABLE TO DETERMINE WHETHER THIS WOULD HAVE CAUSED LOOSENING OF THE ASSEMBLY.

    Description of Event or Problem · 1

    DR. REPORTED THAT PT COMPLAINED THAT THE PRODUCT WAS LOOSE AND/OR SHIFTING. DR. PERFORMED A REVISION SURGERY ON (B)(6) 2013. PT REPORTS NO FURTHER DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54621 PREFERENCE PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MAX AMEDICA CORP. 501370

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR