BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4776968 · Received May 18, 2015

    Report

    Report Number
    2530088-2015-10277
    Event Type
    Injury
    Date Received
    May 18, 2015
    Report Date
    May 4, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    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. MURREY, D.B., ET AL. (2012). SEVEN-YEAR RESULTS OF THE PRODISC-C MULTICENTER RANDOMIZED CLINICAL TRIAL. PROCEEDINGS OF THE NASS 27TH ANNUAL MEETING / THE SPINE JOURNAL, VOLUME 12, PP. 61S-62S. AUTHORS: USA. THIS REPORT IS FOR UNKNOWN PRODISC-C, UNKNOWN PART AND UNKNOWN LOT. (B)(6). (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 ARTICLE: MURREY, D.B., ET AL. (2012). SEVEN-YEAR RESULTS OF THE PRODISC-C MULTICENTER RANDOMIZED CLINICAL TRIAL. PROCEEDINGS OF THE NASS 27TH ANNUAL MEETING / THE SPINE JOURNAL, VOLUME 12, PP. 61S-62S. AUTHORS: USA. THE PURPOSE OF THIS TRIAL IS TO COMPARE THE SAFETY AND EFFICACY OF CERVICAL ARTIFICIAL DISC REPLACEMENT (C-ADR) TO ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY FOR THE TREATMENT OF ONE-LEVEL SYMPTOMATIC CERVICAL DEGENERATIVE DISC DISEASE (SCDD) BETWEEN C3 AND C7. THIS WAS A PROSPECTIVE, RANDOMIZED, CONTROLLED CLINICAL TRIAL. OUTCOME MEASURES INCLUDED: VISUAL ANALOG SCALE (VAS), PAIN AND INTENSITY (NECK AND ARM), VAS SATISFACTION, NECK DISABILITY INDEX (NDI), NEUROLOGICAL EXAM, DEVICE SUCCESS, ADVERSE EVENT OCCURRENCE, AND SHORT FORM-36 (SF-36) STANDARDIZED QUESTIONAIRES. TWO HUNDRED NINE PATIENTS WERE RANDOMIZED AND TREATED (106 ACDF: 103 C-ADR). A NONINFERIORITY DESIGN WITH A 1:1 RANDOMIZATION WAS USED. DEMOGRAPHICS WERE SIMILAR BETWEEN THE 2 PATIENT GROUPS (C-ADR 42.1 YEARS, 44.7% MALE: ACDF 43.5 YEARS, 46.2% MALE). THIS REPORT REFERS TO: SECONDARY SURGICAL PROCEDURES DID SHOW A DIFFERENCE WITH 6/103 IN C-ADR COHORT. C-ADR HAD A LOWER RATE OF SECONDARY SURGERY. ARTICLE DID NOT SPECIFY REASONS FOR SECONDARY SURGICAL PROCEDURES. 8/103 PATIENTS IN THE C-ADR COHORT DEVELOPED BRIDGING BONE AT 7 YEARS. NO DIFFERENCE IN CLINICAL OUTCOMES OF THOSE C-ADR PATIENTS WITH OR WITHOUT BRIDGING BONE. THIS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN QUANTITY OF PRODISC-C WITH AN UNKNOWN PART NUMBER AND LOT NUMBERS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323994 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention