BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 7105337 · Received December 11, 2017

    Report

    Report Number
    8030965-2017-50498
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    April 4, 2017
    Report Date
    November 13, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PRODISC. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER .REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 LITERATURE ARTICLE STORHEIM. K., BERG. L., HELLUM., C., GJERTSEN., O., NECKELMANN., G., ESPELAND., A., KELLER., A. (2017). FAT IN THE LUMBAR MULTIFIDUS MUSCLES PREDICTIVE VALUE AND CHANGE FOLLOWING DISC PROSTHESIS SURGERY AND MULTI-DISCIPLINARY REHABILITATION IN PATIENTS WITH CHRONIC LOW BACK PAIN AND DEGENERATIVE DISC: 2-YEAR FOLLOW-UP OF A RANDOMIZED TRIAL. BMC MUSCULOSKELETAL DISORDERS, 18(145), P. 1-11. NORWAY. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE WHETHER PRE-TREATMENT MULTIFIDUS MUSCLE FAT INFILTRATION PREDICTS THE PATIENT OUTCOME FOLLOWING 2 YEARS OF TREATMENT WITH TDR SURGERY OR MULTI-DISCIPLINARY REHABILITATION. THE STUDY ALSO WORKED TO COMPARE CHANGES IN MULTIFIDUS MUSCLE FAT INFILTRATION FROM PRE-TREATMENT TO 2-YEAR FOLLOW UP BETWEEN TWO TREATMENT GROUPS. THE STUDY INCLUDED 173 PATIENTS RANGING IN BETWEEN THE AGES OF 25-55 WITH EITHER CHRONIC LOW BACK PAIN (LBP), DEGENERATIVE DISC RANDOMIZED TO TDR SURGERY OR MULTI-DISCIPLINARY REHABILITATION. THE STUDY ACTED AS A SECONDARY ANALYSIS OF DATA FROM A 2 YEAR FOLLOW UP OF THESE PATIENTS. THE SECONDARY ANALYSIS OF PATIENTS INCLUDED A RANDOMIZED TRIAL EVALUATING THE EFFECT OF SURGERY WITH DISC PROSTHESIS VERSUS REHABILITATION. THE PATIENTS WERE RANDOMIZED AND TREATED WITH TDR SURGERY OR MULTI-DISCIPLINARY REHABILITATION BETWEEN MAY 2004 AND SEPTEMBER 2007: 86 WERE RANDOMIZED TO SURGERY AND 87 TO REHABILITATION. PATIENTS UNDERWENT PRETREATMENT MAGNETIC RESONANCE IMAGING (MRI) OF THE LUMBAR SPINE 0¿12 MONTHS PRIOR TO INCLUSION AND A FOLLOW-UP MRI WITH CLINICAL INVESTIGATION 2 YEARS AFTER TREATMENT. IN THE PREDICTOR ANALYSIS, PATIENTS CROSSING OVER FROM REHABILITATION TO TDR SURGERY DURING THE 2-YEAR FOLLOW-UP PERIOD WERE ANALYZED IN THE SURGICAL GROUP, AND PATIENTS RANDOMIZED TO SURGERY WHO REFUSED SURGERY AND UNDERWENT REHABILITATION WERE ANALYZED IN THE REHABILITATION GROUP ACCORDING TO AS-TREATED PRINCIPLES. PATIENTS NOT UNDERGOING ALLOCATED INTERVENTIONS AND PATIENTS OPERATED UPON WITH A FUSION WERE EXCLUDED FROM THE PREDICTOR ANALYSIS. WHEN COMPARING CHANGE IN FAT INFILTRATION OVER TIME BETWEEN TREATMENT GROUPS, ALL AVAILABLE PATIENTS WERE EXAMINED ACCORDING TO THE INTENTION-TO-TREAT (ITT) ANALYSIS. ALL PATIENTS WHO UNDERWENT SURGERY WERE IMPLANTED WITH A SYNTHES SPINE PRODISC II. OUT OF 173 PATIENTS INCLUDED IN THE STUDY 144, 147, AND 137 PATIENTS HAD PRETREATMENT MRI AND VALID 2-YEAR DATA ON BACK PAIN, ODI, AND WORK STATUS, RESPECTIVELY. PATIENTS INCLUDED IN THE PREDICTOR ANALYZES AND IN THE BETWEEN GROUPS ANALYSIS OF CHANGE IN FAT INFILTRATION OVER TIME WERE SIMILAR AT BASELINE WITH A MEAN AGE OF ABOUT 45 YEARS WITH CHRONIC LBP FOR WELL OVER 6 YEARS, BMI JUST ABOVE THE LIMIT FOR NORMAL WEIGHT, AND ODI-SCORE OF ABOUT 42 POINTS ON AVERAGE. OVERALL, IT WAS DISCOVERED THAT GRADE 0 PRE-TREATMENT MULTIFIDUS MUSCLE FAT PREDICTED BETTER CLINICAL RESULTS AT 2-YEAR FOLLOW-UP AFTER TDR BUT NOT AFTER REHABILITATION. AT THE 2-YEAR FOLLOW-UP, INCREASED FAT INFILTRATION WAS MORE COMMON IN THE SURGERY GROUP WHERE IT WAS RELATED TO WORSE PAIN AND ODI. THERE WERE NO MALFUNCTIONS OR ADVERSE REPORTED IN REFERENCE TO THE SYNTHES DEVICE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN PRODISC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883490 PROSTHESIS INTERVERTEBRAL DISC MJO OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention