BEUDAMED
    FDA Adverse Event Other Summary report: N

    2246640-1999-00003

    MDR report key: 256917 · Received December 15, 1999

    Report

    Report Number
    2246640-1999-00003
    Event Type
    Other
    Date Received
    December 15, 1999
    Date of Event
    November 9, 1999
    Report Date
    December 15, 1999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A POSTERIOR INTERBODY FUSION PROCEDURE IN 1999, IN WHICH THE ALLEGED MEDICAL DEVICE WAS USED. DURING THE PROCEDURE, THE SURGEON TIRED TO DISTRACT THE L4-L5 DISC SPACE WITH THE ALLEGED DISTRACTOR ASSEMBLY (ATTACHMENT 00-2114-15 AND SHAFT 00-2114-14). THE SURGEON ENCOUNTERED DIFFICULTY DISTRACTING THE DISC SPACE, DUE TO ITS REPORTED TIGHTNESS. AT ONE POINT, THE DISTRACTOR ATTACHMENT SHEARED OFF OF THE DISTRACTOR SHAFT AND BECAME TEMPORARILY LODGED IN THE DISC SPACE. THE BROKEN PIECE WAS SUBSEQUENTLY REMOVED. THE PT WAS REPORTED STABLE WITH NO SEQUELAE ON 11/16/99.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention