BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE FIXATION SYSTEM

    MDR report key: 5113700 · Received September 30, 2015

    Report

    Report Number
    3008524126-2015-00029
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    August 25, 2015
    Report Date
    February 9, 2016
    Manufacturer
    ORTHOFIX INC
    Product Code
    MNI
    PMA / PMN Number
    K080407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SFS SYSTEM SCREW 56-3645, LOT UNKNOWN, UDI (B)(4). SFS SYSTEM SCREW 56-3650, LOT UNKNOWN, UDI (B)(4).

    Additional Manufacturer Narrative · 1

    P/N 56-3645 LOT 0006 MANUFACTURE DATE 03/10/2015, P/N 56-3650 LOT A19 MANUFACTURE DATE 08/17/2012. THE TWO SCREWS WERE RETURNED FOR INVESTIGATION. BOTH OF THE PRESSURE CAPS ARE UNSEATED. PREVIOUS INVESTIGATION REVEALED THE FOLLOWING FOR PRESSURE CAP UNSEATING COMPLAINTS. THE FAILURE MECHANISM FOR THE PRESSURE CAP UNSEATING CAN BE DESCRIBED AS: DISENGAGEMENT OF THE DRIVER AND SCREW BODY DURING SCREW INSERTION-> LOSS OF CO-LINEARITY BETWEEN THE DRIVER AND SCREW AXIS-> UNDESIREABLE CONTACT POINTS, COLLAPSE OF THE RETENTION RING-> UNSEATING OF THE PRESSURE CAP. THOUGH IT IS NOT CLEAR WHAT LEAD TO THE DISENGAGEMENT IN THIS CASE, FACTORS THAT LEAD TO DISENGAGEMENT COULD BE AND NOT LIMITED TO - (1) HIGH DOWNWARD FORCE ON THE OUTER SLEEVE APPLIED BY THE SURGEON DURING SCREW INSERTION (AS IN DRIVING A NON-SELF-TAPPING SCREW WITHOUT PREPARING THE BONE WITH A TAP OR USING AN UNDERSIZED TAPPING METHOD): (2) INCOMPLETE TIGHTENING OF THE KNOB/WING PRIOR TO ATTEMPTING SCREW INSERTION AND/OR APPLYING INCONSISTENT TIGHTENING TORQUE BETWEEN SCREWS (FATIGUE OF THE PERSON LOADING THE SCREWS): (3) ACCIDENTAL HOLDING OF THE DRIVER AT THE KNOB/WING INSTEAD OF AT THE OUTER SLEEVE OR (4) DUE TO INSUFFICIENT LENGTH OF THREAD ENGAGEMENT. USERS SHOULD NOT EXERT A DOWNWARD FORCE ON THE SLEEVE WHEN INSERTING THE BONE SCREW INTO THE PEDICLE. ALSO, THE USER SHOULD NOT HOLD THE KNOB OR WING DURING INSERTION.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING THE SURGERY THE PRESSURE CAP CAME OUT OF TWO DIFFERENT SCREWS CAUSING A DELAY IN THE CASE. NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644408 SPINE FIXATION SYSTEM MULTI-AXIAL SCREW MNI ORTHOFIX INC

    Patients

    Seq Age Sex Outcome Treatment
    1