BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC CERVICAL MEDIUM/5MM-STERILE

    MDR report key: 2895776 · Received January 3, 2013

    Report

    Report Number
    2530088-2013-00002
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS LOT # 2004000476 DOES NOT EXIST IN JDE OR DOCUSPHERE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL DHR COMPLETED ON 9-19-13 WHICH INDICATED THAT THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS COMPLETED: PRODISC-C IS A SPINAL IMPLANT INTENDED AS A REPLACEMENT FOR DISEASED/DEGENERATED INTERVERTEBRAL DISCS OF THE CERVICAL SPINE. THE PRODISC-C TOTAL DISC REPLACEMENT PROCEDURE INVOLVES THE REMOVAL OF A DISEASED/DEGENERATED DISC, AND SUBSEQUENT RESTORATION OF INTERVERTEBRAL DISC HEIGHT AND POTENTIAL FOR MOTION VIA PLACEMENT OF THE IMPLANT. THE COMPLAINT DESCRIPTION STATED THAT A PATIENT WITH PRODISC-C IMPLANTS AT MULTIPLE LEVELS EXPERIENCED CONTINUED PAIN, AND A REVISION SURGERY HAD TO BE PERFORMED. THE PARTS RELATED TO THE COMPLAINT COULD NOT BE EVALUATED AS THEY WERE NOT RETURNED FOR ANALYSIS. IMPLANTATION AT MULTIPLE LEVELS IS CONSIDERED OFF-LABEL USE FOR PRODISC-C IMPLANTS. THE PRODISC-C DESIGN AND CLINICAL RISK MANAGEMENT FILE WAS REVIEWED. PAIN IS LISTED ON THE PRODISC-C PACKAGE INSERT AS ONE OF THE SEVERAL POTENTIAL RISKS ASSOCIATED WITH THIS DEVICE AND IN GENERAL WITH THE IMPLANTATION OF SPINAL IMPLANTS. MULTI-LEVEL IMPLANTATION RESULTING IN MAJOR PAIN IS COVERED IN THE RISK MANAGEMENT FILE. BASED ON THE INFORMATION PROVIDED, NO DESIGN RELATED ISSUES COULD BE IDENTIFIED WITH THE PRODISC-C IMPLANTS. THE DESIGN IS CONSIDERED ADEQUATE FOR THE INTENDED USE OF THE DEVICE. THE COMPLAINT IS INDETERMINATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH THREE PRODISC-C IMPLANTS AT C4-5, C5-6, C6-7 ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, FOR REVISION AND REMOVAL OF HARDWARE. IT WAS REPORTED THE PATIENT WAS CONTINUING TO HAVE SOME PROBLEM WITH PAIN. DURING EXTRACTION OF PRO DISC CERVICAL, THE DISTRACTION PIN IN THE C5 VERTEBRAL BODY TORE THROUGH THE BONE CAUSING THE DISTRACTION PINS TO BE IRRELEVANT. THE SURGEON THEN USED THE VERTEBRAL BODY DISTRACTOR TO CREATE SOME DISTRACTION FOR THE REMOVAL. THE TIP OF THE DISTRACTOR BROKE WHILE TRYING TO PERFORM THE DISTRACTION. THE SURGEON WAS ABLE TO SUCCESSFULLY REMOVE THE THREE, PDC IMPLANTS WITH THE FORKED OSTEOTOME, INLAY SEPARATOR, AND THE STRAIGHT OSTEOTOMES. PATIENT WAS REVISED TO A FUSION WITH COMPETITORS HARDWARE. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599 PRODISC CERVICAL MEDIUM/5MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE SSC205C 2004000476

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention PRODISC-C IMPLANTS, DISTRACTOR