BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 3833374 · Received May 27, 2014

    Report

    Report Number
    2530088-2014-10139
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR ONE UNKNOWN PRODISC-C IMPLANT. IMPLANTED DATE UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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

    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 CLINICAL STUDY PATIENT ID# CAC-02-A12 WAS IMPLANTED WITH AN UNKNOWN PRODISC-C AT AN UNKNOWN LEVEL ON AN UNKNOWN DATE AND IS EXPERIENCING NUMBNESS, TINGLING AND BURNING. ON (B)(6) 2013, THE PATIENT RETURNED TO THE STUDY SITE. UPON EXAMINATION, THE INVESTIGATOR NOTED THE PATIENT HAS WORSENING SYMPATHETIC DYSTROPHY SYMPTOMS. PERMANENT NEUROLOGIC IMPAIRMENT OF NUMBNESS, TINGLING AND BURNING WAS NOTED. THE SEVERITY OF THE SYMPTOMS ARE MODERATE AND INTERFERE WITH SOME DAILY ACTIVITIES. THE PATIENT IS UNDER THE CARE OF A NEUROLOGIST. ON (B)(6) 2013, THE PATIENT RETURNED TO THE STUDY SITE. IMAGING WAS TAKEN ON AN UNKNOWN DATE. THE INVESTIGATOR NOTED THE PATIENT HAS C4-C6 FOCAL KYPHOSIS AND C5-C6 DEGENERATIVE CHANGES OBTAINED FROM THE IMAGING. PERMANENT NEUROLOGIC IMPAIRMENT OF NUMBNESS, TINGLING AND BURNING WAS NOTED. THE SEVERITY OF THE SYMPTOMS ARE MILD AND DO NOT INTERFERE WITH DAILY ACTIVITIES. AN MRI OF THE CERVICAL SPINE WAS REQUESTED AND THE PATIENT WILL FOLLOW-UP ONCE THIS HAS BEEN COMPLETED. THE INVESTIGATOR ALSO CONCLUDED THE ADVERSE EVENTS WERE DEFINITELY NOT RELATED TO THE TYPE OF SURGERY, AND DEFINITELY NOT RELATED TO THE IMPLANT. THE IMPLANT HAS NOT BEEN EXPLANTED. THIS REPORT IS FOR ONE UNKNOWN PRODISC-C IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ON JUNE 10, 2013, THE PATIENT RETURNED TO STUDY SITE. UPON EXAMINATION, THE INVESTIGATOR NOTED BEGINNING (B)(6) 2013, THE PATIENT WAS EXPERIENCING WORSENING SYMPATHETIC DYSTROPHY SYMPTOMS. PERMANENT NEUROLOGIC IMPAIRMENT OF NUMBNESS, TINGLING AND BURNING WAS NOTED. THE PATIENT IS UNDER THE CARE OF A NEUROLOGIST. IMAGING WAS TAKEN ON AN UNKNOWN DATE. THE INVESTIGATOR NOTED BEGINNING (B)(6) 2013, THE PATIENT HAS C4-C5 FOCAL KYPHOSIS AND C5-C6 DEGENERATIVE CHANGES OBTAINED FROM THE IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310880 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention