BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 POLYAXIAL SCREW 6.5X45MM CANULATED

    MDR report key: 3829695 · Received May 7, 2014

    Report

    Report Number
    3005673311-2014-00049
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    NKB
    PMA / PMN Number
    K071945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR SITE EVALUATION: WAITING FOR PRODUCT RETURN.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PRIMARY SURGERY: (B)(6) 2014 WITHOUT ANY ABNORMALITIES. THE SET SCREWS WERE LOCKED WITH THE TORQUE WRENCH ACCORDINGLY. THE PT HAD PAIN AFTER THREE MONTHS. DURING THE FIRST CHECK UP IT WAS VISIBLE THAT THE CAGE LWK 5/S1 WAS DISPLACED IN DIRECTION OF THE SPINAL CARD. RESULT OF MRT: LOOSENING SET SCREW WE S1. COMPLETE REMOVAL OF S4 FIXATEUR, CHANGE TO BREHM SYNTHES CAGE. SURGEON HAS THE IMPRESSION, THAT THE STABILITY OF S4 IS INSUFFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274859 S4 POLYAXIAL SCREW 6.5X45MM CANULATED BONE SCREW NKB AESCULAP AG & CO. KG SW346T 51697987

    Patients

    Seq Age Sex Outcome Treatment
    1 Other