BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADJ OA DEFIANCE BRACE

    MDR report key: 1135710 · Received August 26, 2008

    Report

    Report Number
    2020737-2008-00001
    Event Type
    Other
    Date Received
    August 26, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 22, 2008
    Manufacturer
    DJO, LLC.
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD SURGICAL REPAIR TO HER MENISCUS, RIGHT KNEE, AND WAS PRESCRIBED OSTEOARTHRITIS BRACE BY HER DOCTOR TO TREAT HER PAIN. IT IS STATED BY THE PT'S DOCTOR, SHE HAD A PERONEAL NERVE IRRITATION FROM HER BRACE, WHICH CAUSED HER SIGNIFICANT SYMPTOMS AND DISCONTINUATION OF USAGE OF THE BRACE. BUT THE NERVE INJURY IS MILD, HER FUNCTION REALLY IS QUITE GOOD AND NO EMG IS REQUIRED. DJO MEDICAL ADVISOR, BELIEVES THAT THE PATIENT'S SYMPTOMS SHOULD BE RELIEVED FROM THE DISCONTINUATION OF THE BRACE, AND IT IS POSSIBLE THAT A PERMANENT IMPAIRMENT OR DAMAGE MAY OCCUR, IF THE PATIENT CONTINUES WEARING THE BRACE WITHOUT INTERVENTION. THE DEVICE WAS FITTED BY HER DOCTOR AND WAS A GOOD FIT WITH NO PROBLEMS. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. BASED ON THE TRENDING ANALYSIS, NO REPORTS OF SIMILAR INJURY DURING THE PRECEDING 180 DAYS. DJO WILL FOLLOW UP WITH THE PATIENT IN A FEW WEEKS.

    Description of Event or Problem · 1

    PATIENT BEGAN USING THE BRACE FOR HER ARTHRITIS IN 2008, AND SAW DOCTOR DUE TO NUMBNESS AND TINGLING. THE DOCTOR STATED THAT THE PATIENT WAS TENDER OVER THE PERONEAL NERVE AT THE RIGHT KNEE, BUT SHE DID HAVE SENSATION IN THE FIRST WEB SPACE. SHE HAS GOOD DORSIFLEXION OF HER BIG TOE, ANKLE, ANTERIOR TIB AS WELL AS PERONEAL EVERTORS. DIAGNOSIS IS MILD PERONEAL NERVE INJURY RIGHT KNEE, DUE TO A PERONEAL NERVE IRRITATION FROM HER OSTEOARTHRITIS BRACE. THE DOCTOR RECOMMENDED TO STOP WEARING THE BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJ OA DEFIANCE BRACE NONE ITQ DJO, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention