BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C SIZ L H6

    MDR report key: 7526573 · Received May 18, 2018

    Report

    Report Number
    8030965-2018-53849
    Event Type
    Injury
    Date Received
    May 18, 2018
    Report Date
    May 1, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MJO
    UDI-DI
    07612335115866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART NUMBER: SSC356H, SYNTHES LOT NUMBER: 1923729: RELEASE TO WAREHOUSE DATE: 17. JULY 2008 EXPIRY DATE: 01. JULY 2013, MANUFACTURING SITE: (B)(4): NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LISTED BELOW IS THE MATERIAL COMPOSITION OF THE PRODISC C AND IT DOES NOT CONTAIN ANY METHYL METHACRYLATE. THE SYNTHES PRODISC-C IMPLANT END PLATES ARE A COBALT CHROMIUM MOLYBDENUM ALLOY, MADE TO (B)(6) SPECIFICATION (B)(4) AND THE FOLLOWING IS A LISTING OF THE ELEMENTS THAT MAKE UP THIS ALLOY. IN ADDITION TO THE FOLLOWING MATERIALS, THE SURFACES OF THE ENDPLATES ARE COATED WITH COMMERCIALLY PURE TITANIUM AND IN BETWEEN THE ENDPLATES IS AN INLAY MADE OF ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE. ELEMENT COMPOSITION BY PERCENTAGE. CARBON (C) 0.14 MAXIMUM. CHROMIUM (CR) 26.00 TO 30.00. MOLYBDENUM (MO) 5.0 TO 7.0. NICKEL (NI) 1.0 MAXIMUM. IRON (FE) 0.75 MAXIMUM. SILICON (SI) 1.0 MAXIMUM. MANGANESE (MN) 1.0 MAXIMUM. NITROGEN (N) 0.25 MAXIMUM. COBALT (CO) BALANCE. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    PATIENT¿S WEIGHT IS UNKNOWN. DEVICE NOT EXPLANTED YET. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE (510K): 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT MAY BE HAVING A REACTION STEMMING FROM TWO PRODISC-C (PDC) IMPLANTS RECEIVED ON (B)(6) 2010. THE DOCTOR IS SPECIFICALLY LOOKING FOR INFORMATION REGARDING THE INCLUSION OF METHYL METHACRYLATE IN EITHER THE PDC IMPLANT OR ANY OF THE OTHER MATERIALS USED IN THE SURGERY. THIS REPORT IS FOR ONE (1) PRODISC-C SIZE L. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369610 PRODISC-C SIZ L H6 PROSTHESIS INTERVERTEBRAL DISC MJO OBERDORF SYNTHES PRODUKTIONS GMBH 1923729 07612335115866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention