BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT LARGE 5MM-STERILE

    MDR report key: 3871517 · Received June 13, 2014

    Report

    Report Number
    2530088-2014-10158
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: THE FOLLOWING DOCUMENTS WERE REVIEWED: DEVICE HISTORY RECORDS CHECK LISTS, PACKING PROCESS SHEET AND PACKAGING LABEL LOG. REVIEW OF THE PROCESS SHEET SHOWS THAT THE STERILE PACK TESTING WAS WITHIN SPECIFICATION AND THAT THE SECONDARY PACKAGING WAS WITHIN SPECIFICATION. THE DEVICE HISTORY RECORDS RELEASE CHECK LISTS DO NOT SHOW ANY NON-CONFORMITY. REVIEW OF THE LOT SHOWS THAT THE PARTS WERE PROCESSED WITHIN SPECIFICATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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) 2014 THE PATIENT UNDERWENT A REMOVAL OF A PRODISC-C AT C5-C6 DUE TO ON-GOING PAIN AND SUBSIDENCE OF THE INFERIOR ENDPLATE INTO THE ANTERIOR PORTION OF THE C6 VERTEBRAL BODY. ALL OF THE REMOVED HARDWARE WAS INTACT. THE PATIENT WAS REVISED TO AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). THE PATIENT NEVER FELT RELIEF FROM THE INITIAL TOTAL DISC REPLACEMENT PROCEDURE, WHICH WAS PERFORMED ON (B)(6) 2014. THERE WAS NO REPORTED SURGERY DELAY. THE PATIENT¿S OUTCOME WAS REPORTEDLY FINE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349741 PRODISC-C IMPLANT LARGE 5MM-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE 7220031

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention