BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE TAP

    MDR report key: 371609 · Received January 9, 2002

    Report

    Report Number
    2184052-2002-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2002
    Date of Event
    December 10, 2001
    Report Date
    January 9, 2002
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BAK/C INSTRUMENT SET HAD TWO 12 MM BONE TAPS AND NO 10 MM BONE TAP. THE EXTRA 12 MM BONE TAP HAD BLUE TAPE ON IT WHICH INDICATES IT IS A 10 MM TAP. THE DOCTOR WAS PLACING A 10MM INOLANT. DUE TO NO 10MM BONE TAP THE SURGEON COULD NOT TAP BUT DECIDED TO PLACE THE BAK/C IMPLANT ANYWAY. THE IMPLANT WOULD NOT GO IN ALL THE WAY AND SAT PROUD. UPON X-RAY, IT WAS NOTICED THAT THE CAGE WAS NOT STABILIZED, AND SURGEON OPTED TO ADD A TRINICA FIXATION SYSTEM TO HELP STABILIZE THE AREA. 1-HOUR EXTRA WAS ADDED TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE TAP INSTRUMENTATION LXH SULZER SPINE-TECH PR0102 P980254

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention