BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1241004 · Received November 21, 2008

    Report

    Report Number
    6000034-2008-00675
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 3, 2008
    Report Date
    October 20, 2010
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LABELING: THE TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED A SODIUM ASSAY RESULT OF 112 MMOL/L ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER RETESTED THE SAMPLE ON ANOTHER C8000 ANALYZER IN THE LAB AND GENERATED A RESULT OF 139 MMOL/L. THE CUSTOMER THEN RETESTED THE SAMPLE ON THE INITIAL C8000 ANALYZER AND GENERATED A RESULT OF 141 MMOL/L. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. A SERVICE CALL WAS INITIATED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, MEDWATCH UF REPORT (B)(4) WAS RECEIVED: AFTER A DA VINCI DOUBLE FENESTRATED INSTRUMENT WAS REMOVED FROM THE PT (ROBOTIC ASSISTED LAP ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY), THE INSTRUMENT TIP BROKE OFF AND WAS NOT DETECTED BY X-RAY. THE SURGEON OPENED, TISSUE MORCELLATED, NO IDENTIFIABLE PART FOUND IN WOUND OR MORCELLATED TISSUE. THE AREA WAS IRRIGATED WELL AND SEARCHED - NO FOREIGN OBJECTS WERE DETECTED IN THE WOUND AREA.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, FOLLOWING THE IMPLANT SURGERY, THE PATIENT REPORTED RECURRENT PAIN, REDNESS, DRAINAGE AT THE IMPLANT SITE AND SKIN OVERGROWTH OF THE ABUTMENT. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SOME OF THE SKIN OVERGROWTH WAS REMOVED. THE SURGEON REPORTEDLY BELIEVES THE PATIENT HAD CHRONIC INFECTION AND THAT THE FIXTURE SHOULD BE EXPLANTED. AS OF THE DATE OF THIS REPORT, 2008, THE PATIENT HAS NOT INFORMED THE SURGEON WHETHER HE WILL HAVE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention