BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 3780988 · Received April 30, 2014

    Report

    Report Number
    2530088-2014-10074
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 20, 2011
    Report Date
    April 15, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PT AGE: MEAN AGE 41.8 +/- 7.73 YEARS FOR TOTAL DISC REPLACEMENT PRODISC-L GROUP (165 PATIENTS). PT SEX: TOTAL 165 PATIENTS IN PRODISC-L GROUP: 95 MALES AND 70 FEMALES. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR 8 UNKNOWN PRODISC-L, SUPERIOR ENDPLATE, UNKNOWN PART/UNKNOWN LOT. IMPLANT DATE: UNKNOWN. R. DELAMARTER ET AL (2011), PROSPECTIVE, RANDOMIZED, MULTICENTER FOOD AND DRUG ADMINISTRATION INVESTIGATIONAL DEVICE EXEMPTION STUDY OF THE PRODISC-L TOTAL DISC REPLACEMENT COMPARED WITH CIRCUMFERENTIAL ARTHRODESIS FOR THE TREATMENT OF TWO-LEVEL LUMBAR DEGENERATIVE DISC DISEASE, THE JOURNAL OF BONE AND JOINT SURGERY, VOL 93, 705-715. 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. 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 JOURNAL ARTICLE "PROSPECTIVE, RANDOMIZED, MULTICENTER FOOD AND DRUG ADMINISTRATION INVESTIGATIONAL DEVICE EXEMPTION STUDY OF THE PRODISC-L TOTAL DISC REPLACEMENT COMPARED WITH CIRCUMFERENTIAL ARTHRODESIS FOR THE TREATMENT OF TWO-LEVEL LUMBAR DEGENERATIVE DISC DISEASE." A TOTAL OF 237 PATIENTS WERE TREATED IN A RANDOMIZED CONTROLLED TRIAL DESIGNED AS A NON-INFERIORITY STUDY. THE PURPOSE OF THE STUDY WAS TO DETERMINE THE 24-MONTH RESULTS OF A CLINICAL TRIAL OF THE PRODISC-L TOTAL DISC REPLACEMENT AS COMPARED WITH SPINAL FUSION FOR THE TREATMENT OF LUMBAR DEGENERATIVE DISC DISEASE AT TWO CONTIGUOUS VERTEBRAL LEVELS FROM L3 TO S1. PATIENT RANDOMIZATION WAS PERFORMED WITH USE OF A 2:1 RATIO OF TOTAL DISC ARTHROPLASTY TO CIRCUMFERENTIAL ARTHODESIS. IN THE TOTAL DISC REPLACEMENT GROUP 14 PATIENTS WERE TREATED AT L3-L5 LEVEL AND 151 PATIENTS WERE TREATED AT L4-S1 LEVEL. 4 PATIENTS OF 165 PATIENTS IN THE TOTAL DISC REPLACEMENT GROUP HAD A SECONDARY SURGICAL PROCEDURE AT THE INDEX LEVELS OR LEVELS. THREE PATIENTS UNDERWENT A SECONDARY SURGICAL PROCEDURE FOR POSTERIOR DECOMPRESSION. ONE DURAL TEAR IN THE TOTAL DISC REPLACEMENT GROUP OCCURRED DURING THE PREPARATION OF THE DISC SPACE AS A BRIDGING OSTEOPHYTE AND CALCIFIED DISC LIMITED THE OPENING OF THE POSTERIOR DISC SPACE. THE DURAL RENT WAS SUCCESSFULLY REPAIRED. THIS IS REPORT 4 OF 6 FOR (B)(4). THIS REPORT FOR UNKNOWN PRODISC-L, SUPERIOR ENDPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260437 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention