BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGOGE PEDICLE SCREW SYSTEM

    MDR report key: 2632092 · Received May 25, 2012

    Report

    Report Number
    3008959459-2012-00001
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    April 26, 2012
    Report Date
    April 26, 2012
    Manufacturer
    ROYAL OAK MEDICAL DEVICES
    Product Code
    NKB
    PMA / PMN Number
    K110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS AN ISOLATED INCIDENT ATTRIBUTED TO AN ERROR IN USE OF THE DEVICE. ONE (1) SET SCREW (P/N PS 5-4001, LOT 10672-01) USED TO SET THE ROD IN PLACE IN THE PEDICLE SCREW SYS WAS STRIPPED AND CROSS THREADED DURING USE. THIS OCCURRED BECAUSE THE SURGEON DID NOT USE ANTI-TORQUE SLEEVE AS RECOMMENDED IN THE SURGICAL TECHNIQUE, AND THUS, THE HEAD SPLAYED. THE SET SCREW WAS DISPOSED OF AND REPLACED WITH A NEW SET SCREW WITHIN THE CONSTRUCT BEING IMPLANTED. THE SURGERY WAS NOT DELAYED AND THE SURGEON REPORTED NO ADVERSE EVENT. ROYAL OAK MED DEVICES REVIEWED THE DEVICE HISTORY RECORD FOR P/N PS 5-4001, LOT 10672-01 AND DETERMINED THAT THERE WAS NO EVIDENCE WITHIN THE FILE TO INDICATE THAT THE PART WOULD CAUSE THE DEVICE TO FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGOGE PEDICLE SCREW SYSTEM NKB, MNH, MNI NKB ROYAL OAK MEDICAL DEVICES 10672-01

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention