BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4771681 · Received May 14, 2015

    Report

    Report Number
    2520274-2015-13757
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    April 28, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THIS REPORT IS FOR UNKNOWN SUPERIOR PRODISL IMPLANT , UNKNOWN QUANTITY, UNKNOWN ITEM NUMBER AND UNKNOWN LOT NUMBER. UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(6). DECREASED DISC HEIGHT, ILIAC VEIN AND DURAL TEARS. 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 LITERATURE ARTICLE; ZIGLAR J.E. AND DELAMARTER R.B. (2013) ¿DOES 360 LUMBAR SPINAL FUSION IMPROVE LONG-TERM CLINICAL OUTCOMES AFTER FAILURE OF CONSERVATIVE TREATMENT IN PATIENTS WITH FUNCTIONALLY DISABLING SINGLE-LEVEL DEGENERATIVE LUMBAR DISC DISEASE? RESULTS OF 5-YEAR FOLLOW-UP IN 75 POSTOPERATIVE PATIENTS.¿ INTERNATIONAL JOURNAL OF SPINE SURGERY 7 (2013) EL-E7 (US ARTICLE). THIS ARTICLE REPORTS ON SURGICAL TREATMENT OF PATIENTS WITH MECHANICAL DEGENERATIVE DISC DISEASE. STUDY DESIGNED FOR PATIENTS WITH SPECIFIC INCLUSION/EXCLUSION CRITERIA IN WHOM AT LEAST 6 MONTHS OF CONSERVATIVE THERAPY HAS FAILED AND WHO ARE THEN OFFERED A STANDARDIZED SURGICAL PROCEDURE AND ARE FOLLOWED UP FOR 5 YEARS. THE STUDY GROUP WAS COMPOSED OF THE PATIENTS IN THE PROSPECTIVE, RANDOMIZED FOOD AND DRUG ADMINISTRATION INVESTIGATIONAL DEVICE EXEMPTION TRIAL COMPARING PRODISC-L WITH 360 FUSION FOR THE TREATMENT OF SINGLE-LEVEL SYMPTOMATIC DISC DEGENERATION. OF 80 PATIENTS RANDOMIZED TO 360 FUSION AFTER FAILURE OF NON-OPERATIVE CARE, 75 PATIENTS WITH AVERAGE AGE OF 40 YEARS, RECEIVED INTERVENTION WITH SINGLE-LEVEL FUSIONS. METHODS FOR THIS STUDY: PATIENTS WITH SYMPTOMATIC SINGLE DEGENERATIVE DISC DISEASE (DDD) WERE TREATED IN RANDOMIZED CLINICAL TRIAL THAT EVALUATED TOTAL DISC REPLACEMENT COMPARED WITH CIRCUMFERENTIAL FUSION. FOLLOW-UP OF THIS TREATMENT WAS 97% AT 2 YEARS AND 75% AT 5 YEARS AND SERVES AS THE BASIS FOR THIS REPORT. PATIENTS IN THE TRIAL HAD AN AVERAGE OF 9 MONTHS OF NON-OPERATIVE TREATMENT. AFTER FUSION, PATIENTS HAD SIGNIFICANT IMPROVEMENTS IN PAIN, FUNCTIONAL STATUS AND QUALITY OF LIFE. SPECIFICALLY, OVER 80% OF PATIENTS IN THIS STUDY HAD IMPROVEMENTS IN RECREATIONAL STATUS WITH INDICATING SUBSTANTIAL IMPROVEMENTS IN LIFE QUALITY THAT WERE NOT AFFORDED BY MONTHS OF CONSERVATIVE CARE. THE 5-YEAR RESULTS ANALYSIS OF 75 PATIENTS INVOLVED IN A MULTICENTER, MULTI-SURGEON TRIAL SUPPORT 360 FUSION SURGERIES AS A PREDICTABLE AND LASTING TREATMENT OPTION TO IMPROVE PAIN AND FUNCTION IN PROPERLY SELECTED PATIENTS WITH MECHANICAL DEGENERATIVE DISC DISEASE. COMPLICATIONS INCLUDE AT 5 YEAR FOLLOW UP 4 FUSION PATIENTS UNDERWENT SECONDARY SURGERY BUT WERE NOT CONSIDERED TO HAVE DEVICE FAILURE BECAUSE THE DEVICE OR INTENDED TREATMENT WAS NOT ALTERED IN ANY WAY. THESE PATIENTS UNDERWENT ROUTINE HARDWARE REMOVAL FOR PAIN. AT 5 YEAR FOLLOW UP 4 FUSION PATIENTS WERE REPORTED WITH DISC HEIGHT DECREASE. POSTOPERATIVE; RETROGRADE EJACULATION WAS REPORTED IN 1 PATIENT, 2 PATIENTS WITH WOUND INFECTIONS TREATED SUCCESSFULLY WITH MEDICATION AND 1 PATIENT WITH DEEP VENOUS THROMBOSIS SUCCESSFULLY TREATED WITH MEDICATION. (SI) THIS REPORT IS 4 OF 6 ITEMS FOR (B)(4). UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THIS REPORT IS FOR AN UNKNOWN SUPERIOR PDL IMPLANT, UNKNOWN PART/UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314946 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention