BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF TRIAL RASP FLUSH - 31X24 - H.14 - L.10°

    MDR report key: 7303038 · Received February 28, 2018

    Report

    Report Number
    3005180920-2018-00101
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    January 29, 2018
    Report Date
    April 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED ON 27 MARCH 2018 BY (B)(4) PRODUCT MANAGER: THE STATEMENT PROPOSED DURING THE PRELIMINARY INVESTIGATION IS CONFIRMED BY THE VISUAL INSPECTION. THE YELLOW DOT POPPED OFF PROBABLY DUE TO THE FRICTION WITH BETWEEN THE ANTERIOR AREA OF THE RASP AND THE BONE OR AND HARD SURFACE. BATCH REVIEW PERFORMED ON 04 APRIL 2018: LOT 1550098: (B)(4). NO ANOMALIES FOUND RELATED TO THE ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION PERFORMED BY R AND D PRODUCT MANAGER: THE YELLOW DOT POPPED OFF PROBABLY DUE TO THE FRICTION BETWEEN THE ANTERIOR AREA OF THE RASP AND THE BONE. A DETAILED ANALYSIS CAN BE PERFORMED DURING THE VISUAL INSPECTION.

    Description of Event or Problem · 1

    THE SURGEON WAS UTILIZING A TRIAL RASP FLUSH TO PREPARE THE DISC SPACE. DURING THIS TIME THE YELLOW DOT ON THE SIDE OF THE TRIAL RASP POPPED OFF WHILE INSIDE THE PATIENT. THE SURGEON WAS ABLE TO LOCATE THE YELLOW DOT AND REMOVE IT FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145140 ALIF TRIAL RASP FLUSH - 31X24 - H.14 - L.10° SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1550098

    Patients

    Seq Age Sex Outcome Treatment
    1 Other