BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPBITING PITUITARY

    MDR report key: 4151512 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03909
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 17, 2014
    Report Date
    March 9, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE UPPER/DYNAMIC ARM OF THE INSTRUMENT HAS BROKEN OFF JUST FORWARD OF THE PIVOT PIN. A MICROSCOPIC REVIEW OF THE FRACTURE SURFACE REVEALS OF A FAIRLY BRITTLE FRACTURE WITH INDICATIONS THAT THERE MATERIAL WAS IN SOME TORSION WHEN THE FRACTURE OCCURRED. THIS IS CONSISTENT WITH A TWISTING MOTION THROUGH THE HANDLE. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT MAST SURGERY, DURING THE PROCEDURE, THE INSTRUMENT BROKE AND A FRAGMENT OF THE INSTRUMENT R EMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633289 UPBITING PITUITARY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC GZ10G050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other