BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHESS 11MM TRANSFORMAINAL LUMBAR INTERBODY

    MDR report key: 5492303 · Received April 14, 2005

    Report

    Report Number
    5492303
    Event Type
    Injury
    Date Received
    April 14, 2005
    Date of Event
    May 1, 2004
    Report Date
    April 12, 2005
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO MD OFFICE (B)(6) 2004 STATING HE REINJURED HIS BACK. (ROLLED OVER IN BED AND HAD INCREASING PAIN.) PATIENT REPORTED THAT FOLLOWING SURGERY IN (B)(6) 2004 HE HAD A FEW MONTHS OF RELIEF. PAIN DESCRIBED AS CONSTANT, ACHY; PAIN RATED AT A 7 ON THE PAIN SCALE. PATIENT TOOK PERCOCET 5 MGM 1 EVERY 4 HOURS WHICH RELIEVED PAIN. PATIENT ALSO REPORTED OVER PAST FEW WEEKS SOME PAIN INTO FLE. REPORTED NUMBNESS INTO BILATERAL FEET. BACK PAIN EQUAL TO LEG PAIN. NO BOWEL/BLADDER DYSFUNCTION. RELIEVED SOMEWHAT WITH REST AND MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHESS 11MM TRANSFORMAINAL LUMBAR INTERBODY 6.0 65MM SOFT CURVED TITANIUM ROD NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention