BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 3793568 · Received May 6, 2014

    Report

    Report Number
    2530088-2014-10093
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 15, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE STUDY INCLUDED 173 PATIENTS, AGED 25-55. NINETY-ONE PATIENTS WERE FEMALE. IMAGING- PRE-OPERATIVE MRI, INTRAOPERATIVE FLUOROSCOPY. RELEVANT PMH: THIS WAS A PROSPECTIVE RANDOMISED MULTICENTRE STUDY CONDUCTED AT FIVE UNIVERSITY HOSPITALS IN NORWAY AND INCLUDED PATIENTS WITH LOW BACK PAIN FOR AT LEAST ONE YEAR, OSWESTRY DISABILITY INDEX OF AT LEAST 30 POINTS, AND DEGENERATIVE CHANGES IN ONE OR TWO LOWER LUMBAR SPINE LEVELS (L5/L5 OR L5/S1, OR BOTH). PATIENTS WERE INCLUDED IN THE PERIOD BETWEEN APRIL 2004 AND MAY 2007 AND WERE TREATED WITHIN THREE MONTHS AFTER RANDOMIZATION. THIS REPORT IS FOR 2 UNKNOWN PRODISC-L SUPERIOR ENDPLATES. REPORT SOURCE: HELLUM, C. (2011). SURGERY WITH DISC PROSTHESIS VERSUS REHABILITATION IN PATIENTS WITH LOW BACK PAIN AND DEGENERATIVE DISC: TWO YEAR FOLLOW-UP OF RANDOMISED STUDY. BMJ 2011; 342:D2786, DOI: 10.1136/BMJ.D2786. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ¿SURGERY WITH DISC PROSTHESIS VERSUS REHABILITATION IN PATIENTS WITH LOW BACK PAIN AND DEGENERATIVE DISC: TWO YEAR FOLLOW-UP OF RANDOMISED STUDY¿. THIS WAS A PROSPECTIVE RANDOMISED MULTICENTRE STUDY CONDUCTED AT FIVE UNIVERSITY HOSPITALS IN (B)(6) THAT INCLUDED 173 PATIENTS, AGED 25-55, WITH LOW BACK PAIN FOR AT LEAST ONE YEAR, OSWESTRY DISABILITY INDEX OF AT LEAST 30 POINTS, AND DEGENERATIVE CHANGES IN ONE OR TWO LOWER LUMBAR SPINE LEVELS (L5/L5 OR L5/S1, OR BOTH). PATIENTS WERE INCLUDED IN THE PERIOD BETWEEN APRIL 2004 AND MAY 2007 AND WERE TREATED WITHIN THREE MONTHS AFTER RANDOMIZATION. EIGHTY-SIX PATIENTS (40 NOTED TO BE WOMEN) WERE RANDOMISED TO SURGERY, WHICH CONSISTED OF REPLACEMENT OF THE DEGENERATIVE INTERVERTEBRAL LUMBAR DISC WITH AN ARTIFICIAL LUMBAR DISC, PRODISC II. THE REHABILITATION GROUP, WHICH CONSISTED OF 87 PATIENTS (51 NOTED TO BE WOMEN), RECEIVED OUTPATIENT TREATMENT IN GROUPS AT THE INVOLVED UNIVERSITY HOSPITALS, WHICH LASTED ABOUT 60 HOURS OVER THREE TO FIVE WEEKS. TREATMENT CONSISTED OF LECTURES AND INDIVIDUAL DISCUSSIONS FOCUSED ON RELEVANT TOPICS, DAILY WORKOUTS FOR INCREASED PHYSICAL CAPACITY, AND CHALLENGING PATIENTS¿ THOUGHTS ABOUT, AND PARTICIPATION IN, PHYSICAL ACTIVITIES PREVIOUSLY LABELED AS NOT RECOMMENDED. THIS IS REPORT 2 OF 10 FOR (B)(4) AND IS FOR 2 UNKNOWN PRODISC-L SUPERIOR ENDPLATES, FOR 2 PATIENTS WHO REPORTED NEW RADICULAR PAIN AT THE 2 YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272514 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention