BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 4768427 · Received May 13, 2015

    Report

    Report Number
    2530088-2015-10209
    Event Type
    Injury
    Date Received
    May 13, 2015
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN PRODISC-C IMPLANT/UNKNOWN QUANTITY/UNKNOWN LOT. UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). 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 ABSTRACT; HEIDER ET AL: LONG- TERM RESULTS OF TOTAL DISC REPLACEMENT IN THE CERVICAL SPINE: A PROSPECTIVE CLINICAL AND X-RAY INVESTIGATION WITH AT LEAST 5 YEAR FOLLOW-UP. EUR SPINE J (2013) 22: PG 2585. GERMANY. THE AIM OF THIS ANALYSIS WAS TO EVALUATE THE LONG- TERM CLINICAL RESULTS AND EFFICACY, THE RADIOGRAPHIC FINDINGS AS WELL AS THE SAFETY OUTCOMES IN A COHORT OF CERVICAL ARTIFICIAL DISC REPLACEMENT (C-ADR) PATIENTS TREATED WITH PRODISC C (SYNTHES, PAOLI, USA) AT LEAST 5 YEARS AFTER SURGERY. THE INITIAL COHORT CONSISTED OF 45 PATIENTS. 38 PATIENTS WERE AVAILABLE FOR FINAL FOLLOW-UP (FU). CLINICAL OUTCOME SCORES VISUAL ANALOGUE SCALE (VAS), NECK DISABILITY INDEX (NDI), AND PATIENT SATISFACTION RATES WERE ACQUIRED WITHIN THE FRAMEWORK OF AN ONGOING PROSPECTIVE NON RANDOMISED CLINICAL TRIAL. THE PATIENT`S EMPLOYMENT STATUS, COMPLICATIONS, REOPERATIONS INCLUDING SYMPTOMATIC ADJACENT SEGMENT DISEASE (ASD) WERE RECORDED. XRAY EVALUATION INCLUDED THE INCIDENCE OF HETEROTOPIC OSSIFICATIONS (HO) AS WELL AS THE RATES AND TIMING OF ASD. THE OVERALL RESULTS REVEALED A HIGHLY SIGNIFICANT IMPROVEMENT FROM BASELINE VAS AND NDI LEVELS AT ALL POSTOPERATIVE FU. VAS SCORES DEMONSTRATED A STATISTICALLY SIGNIFICANT IMPROVEMENT. AS WELL THE NDI BASELINE SHOWED A STABLE IMPROVEMENT. PATIENT SATISFACTION RATES REMAINED STABLE THROUGHOUT THE ENTIRE POSTOPERATIVE COURSE, THE RADIOGRAPHIC RESULTS DEMONSTRATED A LARGE INCIDENCE OF HO AS OF TIME WELL AS STATISTICALLY SIGNIFICANT PROGRESSION OF THE HO IN PROCESS OF TIME. HO GRADE I APPEARED IN 17,3%, GRADE II IN 21,2%, GRADE III IN 28,9%, AND GRADE IV IN 15,3%.. THE OVERALL COMPLICATION RATE (EXCLUDING HO) WAS 13,3%. THE INCIDENCE OF REVISION SURGERY FOR DEVICE RELATED COMPLICATIONS WAS 2,2%. THE INCIDENCE OF ADJACENT-LEVEL SURGERY DUE TO SYMPTOMATIC CLINICAL AND RADIOLOGICAL ASD WAS 4,4%. COMPLICATIONS REPORTED: HETEROTOPIC OSSIFICATION, REVISION DUE TO ADJACENT SEGMENT DISEASE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRO-DISC C IMPLANT, UNKNOWN LOT, UNKNOWN QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314494 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention