BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAR, ROD RECEPTACLE, APELO PEDICLE SYSTEM

    MDR report key: 1659674 · Received April 14, 2010

    Report

    Report Number
    3003855635-2010-00007
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 8, 2010
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K072426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW SHOWED NO ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. VISUAL EXAMINATION OF THE DEVICE SHOWS WITNESS MARKS INDICATING THAT IT WAS ORIGINALLY LOCKED INTO PLACE AND HAD PROPER CONTACT. NO CONCLUSION CAN BE DRAWN. EVENT CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    A LOCKING COLLAR WAS FOUND BACKED OUT FROM PEDICLE SCREW SYSTEM AT UNK TIME POST OP. THE REVISION SURGERY WAS PERFORMED ON (B)(6)2010. NO ADD'L PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAR, ROD RECEPTACLE, APELO PEDICLE SYSTEM LOCKING COLLAR NKB ATLAS SPINE INC. 00885

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention