BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK LUMABER INTERBODY CAGES

    MDR report key: 282385 · Received June 19, 2000

    Report

    Report Number
    MW1019147
    Event Type
    Injury
    Date Received
    June 19, 2000
    Date of Event
    May 18, 2000
    Report Date
    June 17, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD THE SULTZER SPINE-TECH BAK CAGES USED DURING AN L5-S1 LUMBAR FUSION TO TREAT DISKITIS AT THAT LEVEL. HOSP STAY WAS NORMAL AND RECOVERY WAS ON TRACK FOR THE FIRST 3 MONTHS. AFTER THAT PT BEGAN EXPERIENCING MORE AND MORE PAIN. IT TURNED OUT THEIR CAGES WERE MOVING AND THE MOTION WAS CAUSING PAIN AND THE MOTION WAS PREVENTING ANY FUSION FROM OCCURRING. ABOUT 6 MOS AFTER THE INITIAL PROCEDURE, PT HAD A POSTERIOR FUSION 5/18/00 AT THE L5-S1 LEVEL WITH PLATES AND SCREWS TO STABILIZE THE CAGES SO THAT THEY WILL HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK LUMABER INTERBODY CAGES SPINAL FUSION CAGE MAX SULZER SPINE-TECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| O