BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L

    MDR report key: 2192590 · Received July 1, 2011

    Report

    Report Number
    2520274-2011-00503
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 16, 2006
    Report Date
    October 17, 2006
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EXPLANTED. MFR CAN NOT BE DETERMINED WITHOUT A PART NUMBER. REPORT WAS RECEIVED IN COMPLAINT HANDLING UNIT ON (B)(4) 2011. MFR DATE AND 510K/PMA CAN NOT BE DETERMINED WITHOUT A PART NUMBER AND LOT NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT IS PART OF AN (B)(4). A (B)(6) OLD MALE PATIENT, STATUS POST DISC REPLACEMENT AT L4-L5 AND L5-S1 ON (B)(6) 2002 WAS DOING WELL UNTIL (B)(6) 2006. PT WAS MOVING HEAVY EQUIPMENT AND HAD SUDDEN ONSET OF LOW BACK PAIN. PAIN CONTINUED WITH RADICULOPATHY INTO HIS LEFT POSTERIOR THIGH, KNEE PAIN, LEG CRAMPS AND DIFFICULTY WALKING. X-RAYS REVEALED BULGING AT L2-L4. CT/DISCOGRAPHY ON (B)(6) 2006 WITH MULTIPLE ANNULAR FISSURES. PT UNDERWENT POSTERIOR SEGMENTAL INTRUMENTATION WITH DYNESYS AND DECOMPRESSION AT ADJACENT LEVEL L3-L4 ON (B)(6) 2006. PRODISC DEVICES REMAIN INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L PRODISC-L MJO SYNTHES (USA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR PRODISC-L