BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L TRIAL-IMPL L 9° 10

    MDR report key: 8251038 · Received January 15, 2019

    Report

    Report Number
    8030965-2019-59919
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    December 18, 2018
    Report Date
    December 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MJO
    UDI-DI
    07612335116726
    PMA / PMN Number
    P050010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THERAPY DATE NOT IMPLANTED DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: SFW760R LOT NUMBER: A7PA46 (WO# 911515) MANUFACTURING SITE: TUTTLINGEN RELEASE TO WAREHOUSE DATE: 15-NOV-2006 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS CONDUCTED. THE COMPLAINED PART WAS FORWARDED TO THE RESPONSIBLE SUSTAINING ENGINEER FOR EVALUATION. THE PD INVESTIGATION WAS COMPLETED WITH THE FOLLOWING STATEMENT. NO INVESTIGATION CAN BE DONE AS NO PRODISC DEMO SETS ARE AVAILABLE AT INVESTIGATION SITE. DUE TO THIS INFORMATION THE PART WAS FORWARDED TO THE MANUFACTURING PLANT FOR EVALUATION. SUMMARY OF THE MANUFACTURING EVALUATION: THE MANUFACTURING EVALUATION SHOWS THAT THERE WAS NO ISSUE DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITION IS UNREPRODUCIBLE WITHOUT THE APPROPRIATE MATING PART. NO MANUFACTURING ISSUE WAS FOUND DURING INVESTIGATION, THEREFORE NO PRM DOCUMENTS WERE REVIEWED DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING A PRODISC CASE ON S1-L5 / L5-L4, THE PRODISC-L TRIAL IMPLANT DID NOT LOCK INTO THE HANDLE AND THE PRODISC-L DISTRACTOR'S TOOTHED WHEEL WAS JAMMED WHEN TAKING OUT THE DISTRACTOR AND WAS UNABLE TO SLIDE THE UNKNOWN POLYETHYLENE(PE)-INPLAY IN PLACE. THERE WERE NO PROBLEMS WHEN DOING THE TRIAL DISTRACTION BUT HAD TO USE LITTLE FORCE TO GET IT OUT. OTHER TRIALS HAD NO ISSUE. THE PE-INLAY WAS IMPLANTED WITH ANOTHER DISTRACTOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10-MINUTE SURGICAL DELAY. THE PATIENT HAD NO COMPLICATIONS AFTER THE PROCEDURE. CONCOMITANT DEVICE REPORTED: UNKNOWN PE-INLAY (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) PRODISC-L TRIAL-IMPL L 9° 10. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43399 PRODISC-L TRIAL-IMPL L 9° 10 PROSTHESIS, INTERVERTEBRAL DISC MJO OBERDORF SYNTHES PRODUKTIONS GMBH A7PA46 07612335116726

    Patients

    Seq Age Sex Outcome Treatment
    1