BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISS PEDICLE SCREW SYS

    MDR report key: 4058602 · Received August 25, 2014

    Report

    Report Number
    1722511-2014-00005
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP ATTENDING THE SURGERY REPORTED THAT THE PT HAD HARD, SCLEROTIC BONE. IN TAPPING THE PEDICLE, THE SURGEON WAS ROCKING THE TAP BACK AND FORTH WHILE APPLYING A TORQUE WHEN THE TIP PORTION BROKE OFF IN THE L5 PEDICLE. THE SURGEON MADE AN ATTEMPT TO RETRIEVE THE TIP BUT WAS UNABLE TO ACCESS THE BROKEN PORTION. THE SURGEON COMPLETED THE SURGERY BY SKIPPING THE L5 LEVEL AND PLACING PEDICLE SCREWS IN THE ADJACENT LEVELS.

    Description of Event or Problem · 1

    A COMPANY REP REPORTED THAT THE 6.5 MM PEDICLE SCREW TAP BROKE OFF IN SURGERY. THE DOCTOR WAS NOT ABLE TO REMOVE THE TIP AND IT WAS LEFT IN THE VERTEBRAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513599 ISS PEDICLE SCREW SYS 6.5 MM TAP SCREW HWC ORTHO DEVELOPMENT CORP. 652-0065 BCS6411C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention