BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAK/C CERVICAL INTERBODY

    MDR report key: 977847 · Received January 7, 2008

    Report

    Report Number
    2184052-2007-00020
    Event Type
    Other
    Date Received
    January 7, 2008
    Date of Event
    November 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ZIMMER SPINE
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RECEIVED IN ON 20-NOV-07. THE REAMER WAS ADJUSTED TO ALL REAMING DEPTHS AND CLEAN SETTING. THE INSTRUMENT FUNCTIONED CORRECTLY.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE REAMER DURING AN ACDF FROM C3 TO C7. IT WAS REPORTED THAT THE SCRUB TECH SET THE REAMER TO 16MM REAMING DEPTH AND HANDED THE INSTRUMENT TO THE SURGEON. AFTER REAMING, THE SURGEON NOTICED THAT THE REAMER SHAFT WAS LOOSE IN THE SLEEVE. THE SURGEON WAS CONCERNED THAT THE REAMER REAMED BEYOND THE POSTERIOR EDGE OF THE CERVICAL VERTEBRAL BODY. THE SURGEON REPORTED SOME CEREBRAL SPINAL FLUID AT THE SITE BUT NOT BLEEDING. THE SURGEON SUCCESSFULLY INSERTED THE IMPLANT. NEUROMONITORING OCCURRED THROUGHOUT THE SURGERY AND NO SIGNAL CHANGE OCCURRED. THE PATIENT AWOKE AFTER SURGERY AND WAS FINE. THE REP EXAMINED THE INSTRUMENT AFTER SURGERY AND CONCLUDED IT FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAK/C CERVICAL INTERBODY 8MM REAMER HTO ZIMMER SPINE 6200-0015-01 P060409

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other