BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 6057855 · Received October 26, 2016

    Report

    Report Number
    2520274-2016-14929
    Event Type
    Injury
    Date Received
    October 26, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AESCULAP IMPLANT SYSTEM; (2015) ARTIFICIAL LUMBAR DISC. PMA P120024: FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA. 1-94. THIS REPORT IS FOR AN UNKNOWN PDL IMPLANT (UNKNOWN QUANTITY/UNKNOWN LOT). THE INVESTIGATION COULD NOT BE COMPLETED; 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 SUBSEQUENT REVIEW OF THE FOLLOWING CLINICAL STUDY: AESCULAP IMPLANT SYSTEM; (2015) ARTIFICIAL LUMBAR DISC. PMA P120024: FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA. 1-94. THE TRIAL WAS A PROSPECTIVE, MULTI-CENTER, RANDOMIZED (2:1), SINGLE MASKED, CONCURRENTLY CONTROLLED, NON-INFERIORITY CLINICAL TRIAL TO COMPARE THE SAFETY AND EFFECTIVENESS OF THE ARTIFICIAL DISC (ACTIVL) TO ONE OF TWO ALTERNATIVE LUMBAR TOTAL DISC REPLACEMENT CONTROL DEVICES (DEPUY SPINE (CHARITE) OR DEPUY SYNTHES SPINE (PRODISC-L) IN RECONSTRUCTION OF THE DISC AT EITHER L4-L5 OR L5-S1 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR SYMPTOMATIC DEGENERATIVE DISC DISEASE (DDD ) IN SUBJECTS WHO HAD FAILED TO IMPROVE WITH NONOPERATIVE TREATMENT FOR AT LEAST SIX MONTHS PRIOR TO ENROLLMENT. THE CHOICE OF CONTROL DEVICE WAS AT THE DISCRETION OF THE INVESTIGATOR AND SUBJECTS INVOLVED IN THE TRIAL WERE SPECIFICALLY CONSENTED TO ONE OR THE OTHER CONTROL DEVICE PRIOR TO SURGERY. SUBJECTS WERE EVALUATED PREOPERATIVELY, INTRAOPERATIVELY, IMMEDIATELY POSTOPERATIVELY, AND AT 6 WEEKS, 3 MONTHS, 6 MONTHS, 12 MONTHS, 24 MONTHS, AND ANNUALLY THEREAFTER. SUBJECTS WERE TREATED BETWEEN JANUARY 30, 2007 AND DECEMBER 3, 2009. THE DATABASE FOR THIS PREMARKET APPROVAL (PMA) REFLECTED DATA COLLECTED THROUGH APRIL 11, 2013 AND INCLUDED A TOTAL OF 376 SUBJECTS TREATED (INCLUDING BOTH RANDOMIZED AND NON-RANDOMIZED SUBJECTS) AT 18 INVESTIGATIONAL SITES IN THE UNITED STATES. SUBJECTS WERE EVALUATED PREOPERATIVELY, INTRAOPERATIVELY, IMMEDIATELY POSTOPERATIVELY, AND AT 6 WEEKS, 3 MONTHS, 6 MONTHS, 12 MONTHS, 24 MONTHS, AND ANNUALLY THEREAFTER. FOLLOWING COMPLETION OF THE PROCEDURE, SUBJECTS IN BOTH TREATMENT GROUPS RECEIVED POSTOPERATIVE CARE CUSTOMIZED TO THEIR POSTOPERATIVE NEEDS AND DEMONSTRATED PROGRESS. OVERALL SUCCESS WAS DETERMINED BASED ON DATA COLLECTED DURING THE INITIAL 24 MONTHS OF FOLLOW-UP. IN THE PRODISC L CONTROL GROUP, THE MOST FREQUENTLY REPORTED ADVERSE EVENT WAS LUMBAR AND LOWER EXTREMITY PAIN, 5 DEVICE DEFICIENCIES WERE IMPLANT EXPULSION, MALPOSITION, MIGRATION AND SUBSIDENCE AND 3 SUBSEQUENT SURGICAL INTERVENTIONS. ONE RANDOMIZED ACTIVL SUBJECT DIED DURING THE STUDY. THE SUBJECT DIED OF HYPERTROPHIC HEART DISEASE WITH THE EFFECTS OF MULTIPLE DRUGS AS CONTRIBUTING FACTORS. THE CEC ADJUDICATED THE EVENT AS DEATH FROM SUICIDE 146 DAYS AFTER SURGERY, AND THEY DETERMINED IT WAS NOT RELATED TO THE ACTIVL DEVICE. THIS REPORT INVOLVES 7 OF 9 FOR THIS REPORT IS (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-L (SUPERION ENDPLATE) AND REFERS TO THE SERIOUS INJURY / REPORTABLE MALFUNCTION OF 2 UNKNOWN PATIENTS, (1) EXPERIENCED IMPLANT EXPULSION WITH REMOVAL, AND (1) EXPERIENCED MALPOSITION WITH REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708733 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention