BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE

    MDR report key: 8718847 · Received June 20, 2019

    Report

    Report Number
    2939274-2019-58788
    Event Type
    Injury
    Date Received
    June 20, 2019
    Report Date
    May 24, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MJO
    UDI-DI
    10705034763750
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER 09.820.035S. LOT NUMBER: 6894243 . DATE OF MANUFACTURE: 03/14/2012. PLACE OF MANUFACTURE: BRANDYWINE PLANT. PART EXPIRATION DATE: 02/2016. THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO NONCONFORMANCES OR ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS SHIPPED TO THE VENDOR FOR STERILIZATION. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE IMAGES/X-RAYS PROVIDED. VISUAL INSPECTION: PHOTOS/X-RAYS OF THE PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE (P/N 09.820.035S LOT 6894243) WAS RECEIVED SHOWING NO IMPLANT FAILURE/DEFECT. CONCLUSION: NO DEVICE ISSUES WERE OBSERVED DURING INVESTIGATION FOR THE PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE (P/N 09.820.035S LOT 6894243) AS THE PROVIDED X-RAYS DID NOT SHOW ANY IMPLANT FAILURE/DEFECT. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CONCOMITANT MEDICAL PRODUCTS: COMPLAINANT PART IS NOT RETURNED TO MANUFACTURER FOR REVIEW/INVESTIGATION. 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

    (B)(4). THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT C4/C5 PRODISC-C REMOVAL, DUE TO CONTINUED PATIENT PAIN AND FACET ARTHROSIS. ORIGINALLY, THE PATIENT UNDERWENT PDC IMPLANTATION ABOUT 6 YEARS AGO. THE PDC IMPLANT WAS SUCCESSFULLY EXPLANTED AND THE PATIENT WAS REVISED TO DEPUY SYNTHES ZERO-P FUSION, STAND-ALONE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT MEDIUM DEEP 5MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510971 PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 09.820.035S 6894243 10705034763750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention