BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    MDR report key: 6598692 · Received May 30, 2017

    Report

    Report Number
    0001032347-2017-00445
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    December 27, 2012
    Report Date
    May 30, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIANS REPORTS WERE PROVIDED. THE PATIENT REPORTED BROWN SPOTS ON HER FACE WHICH IS A COMMON SYMPTOM OF MELASMA. IT IS HIGHLY UNLIKELY THAT THE MELASMA AND HAIR-LOSS IS IMPLANT RELATED. SEIZURES AND NECROSIS ARE A POTENTIAL SIDE EFFECT OF A STAPH INFECTION; HOWEVER, THE CAUSE OF THE STAPH INFECTION WAS NOT PROVIDED. FOR THE AFOREMENTIONED REASONS, THE COMPLAINT COULD NOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS SUPPLEMENTAL REPORT TWO OF TWO FOR THE SAME EVENT; REFERENCE REPORT 0001032347-2017-00444-1.

    Additional Manufacturer Narrative · 1

    THE SURGEONS DICTATION STATES THE PLATE WAS SECURED USING 4MM AND 5MM SCREWS. THE SCREW PART NUMBERS ARE UNKNOWN AT THIS TIME. THE POTENTIAL PART NUMBERS FOR THE 4MM SCREWS ARE 91-6104, 91-1504, 01-7284, AND 01-7204. THE POTENTIAL PART NUMBERS FOR THE 5MM SCREWS ARE 91-6105, 91-6105X, 91-1505, 91-1805, 01-7285, AND 01-7205 AND 01-7225. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE PART AND LOT NUMBERS ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THE FOLLOWING ARE LISTED AS POSSIBLE ADVERSE EFFECTS IN THE PACKAGE INSERT: METAL SENSITIVITY, OR ALLERGIC REACTION TO A FOREIGN BODY. NECROSIS OF BONE. APART FROM THESE ADVERSE EFFECTS THERE ARE ALWAYS POSSIBLE COMPLICATIONS OF ANY SURGICAL PROCEDURE SUCH AS, BUT NOT LIMITED TO, INFECTION, NERVE DAMAGE, AND PAIN, WHICH MAY NOT BE RELATED TO THE IMPLANT. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00444.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE HAD BRAIN DECOMPRESSION SURGERY ON (B)(6) 2012. SHE INQUIRED ABOUT THE IMPLANT MATERIALS AND IF THEY WERE STAINLESS STEEL. SHE STATED SHE MAY HAVE A NICKEL ALLERGY. THE PATIENT WAS ADVISED OUR PLATES CONSIST OF COMMERCIALLY PURE TITANIUM AND OUR SCREWS ARE TI-6AL-4V. THERE IS NO NICKEL IN OUR PLATES AND/OR SCREWS. THE PATIENT REPORTED RIGHT AFTER HER PROCEDURE IN 2012 SHE BEGAN HAVING SEIZURES AND DEVELOPED BROWN SPOTS ON HER FACE. THE DOCTORS DIAGNOSED HER WITH MELASMA AND PRESCRIBED MEDICATION. AS TIME CONTINUED THE BROWN SPOTS INCREASED IN SIZE AND THE HAIR IN THE AREA BEGAN TO FALL OUT. HER ATTENDING PHYSICIAN REFERRED HER TO AN ALLERGIST AND A DERMATOLOGIST WHO RAN SEVERAL TESTS AND TOOK BIOPSIES OF THE AREAS, THE MOST RECENT DIAGNOSIS IS STAPH INFECTION. THE PATIENT ALSO MENTIONED NECROSIS AROUND HER IMPLANT. THE PATIENT REPORTED SHE HAS AN APPOINTMENT WITH ANOTHER DERMATOLOGIST (B)(6) 2017. FOLLOW UP WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380091 BIOMET MICROFIXATION FACIAL PLATING SYSTEM SCREW, BONE JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other