BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 7113014 · Received December 13, 2017

    Report

    Report Number
    8030965-2017-50601
    Event Type
    Injury
    Date Received
    December 13, 2017
    Report Date
    November 13, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LAUGESEN, L; ET AL (2017) PATIENT-REPORTED OUTCOMES AND REVISION RATES AT A MEAN FOLLOW-UP OF 10 YEARS AFTER LUMBAR TOTAL DISC REPLACEMENT. SPINE, VOL 42(21), 1657-1663. THIS IS A RETROSPECTIVE STUDY TO DETERMINE THE LONG-TERM CLINICAL RESULTS AND PROSTHESIS SURVIVAL IN PATIENTS TREATED WITH LUMBAR TOTAL DISC REPLACEMENT (TDR). SEVENTY-ONE PATIENTS TREATED WITH PRODISC II TDR (SYNTHES, PAOLI, PA) IN THE LUMBAR SPINE FROM 2003 TO 2008 WERE IDENTIFIED. INDICATION OF TDR WAS DEGENERATIVE DISC DISEASE (DDD) DIAGNOSED ON MRI, SHOWING ¿¿BLACK DISC,¿¿ ANNULUS RUPTURE, OR MODIC CHANGES. OF THE 71 PATIENTS, THREE PATIENTS DIED BECAUSE OF UNRELATED CAUSES, LEAVING 68 PATIENTS AVAILABLE FOR FOLLOW-UP. FOUR PATIENTS DECLINED TO PARTICIPATE AND TWO WERE LOST TO FOLLOW-UP. THE REMAINING 62 PATIENTS AGREED TO PARTICIPATE AND WERE ENROLLED. FIVE PATIENTS DID NOT RETURN THE QUESTIONNAIRES AND WERE SUBSEQUENTLY LOST TO FOLLOW-UP. THIS LEFT 57 PATIENTS AVAILABLE FOR FOLLOW-UP. MEAN PATIENT AGE AT THE FINAL FOLLOW-UP WAS 49.6 YEARS (34.5¿79.0), AND THE FOLLOW-UP WAS CONDUCTED AT MEAN 10.6 YEARS (8.1¿12.6 YEARS) POSTOPERATIVELY. THE MAJORITY OF PATIENTS HAD SINGLE-LEVEL TDR (36) FOLLOWED BY TWO-LEVEL TDR (20) AND 1 HAD THREE-LEVEL TDR. OF 57 PATIENTS, 19 PATIENTS (33%) HAD REVISION SURGERY AT FOLLOW-UP. MEAN TIME FROM TDR TO REOPERATION WAS 3.5 YEARS (0.5¿8.8 YEARS), WITH A TOTAL OF 23 SEGMENTS REVISED. INDICATIONS FOR REVISION INCLUDED 14 HAD BACK PAIN AND OR RADICULOPATHY, 1 HAD SPONDYLOSIS, 3 HAD FACET ARTHROSIS AND 1 REVISION WAS UNKNOWN. A COPY OF THE ARTICLE WILL BE SUBMITTED WITH THE MEDWATCH. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC II. THIS REPORT IS FOR 14 UNKNOWN PATIENTS WHO EXPERIENCED BACK PAIN AND OR RADICULOPATHY, 1 HAD SPONDYLOSIS, 3 HAD FACET ARTHROSIS AND 1 REVISION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892911 PROSTHESIS INTERVERTEBRAL DISC MJO OBERDORF : SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention