BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE

    MDR report key: 8759201 · Received July 3, 2019

    Report

    Report Number
    1000022662-2019-00010
    Event Type
    Injury
    Date Received
    July 3, 2019
    Report Date
    July 3, 2019
    Manufacturer
    GRACE MEDICAL, INC.
    Product Code
    ETB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLES ARE PARTIAL OSSICULAR REPLACEMENT PROSTHESES PER FDA PRODUCT CODE ETB AND REGULATION NUMBER 874.3450. A PARTIAL OSSICULAR REPLACEMENT PROSTHESIS IS A DEVICE INTENDED TO BE IMPLANTED FOR THE FUNCTIONAL RECONSTRUCTION OF SEGMENTS OF THE OSSICULAR CHAIN AND FACILITATES THE CONDUCTION OF SOUND WAVE FROM THE TYMPANIC MEMBRANE TO THE INNER EAR. IT WAS REPORTED THAT POST GRANULOMA EXCISION, THE PATIENT REPORTEDLY HAD NO HEARING LOSS AND THE FACIAL PARALYSIS WAS IMPROVING. AS THE PATIENT DID NOT EXPERIENCE HEARING LOSS, THE GRACE MEDICAL, INC.'S NOTCHED TITANIUM BUCKET HANDLE FUNCTIONED AS INTENDED. THIS ADVERSE EVENT IS BEING FILED AS A RESULT OF THE MAUDE ADVERSE EVENT DATABASE REVIEW. NO PRODUCT WAS RETURNED TO GRACE MEDICAL, INC. FOR EVALUATION; THEREFORE, NO EVALUATION CAN BE PERFORMED. A COMPLAINT OR ADVERSE EVENT REGARDING THE GRACE MEDICAL, INC.'S NOTCHED TITANIUM BUCKET HANDLE WAS NOT REPORTED TO GRACE MEDICAL, INC. ASSOCIATED WITH THIS ADVERSE EVENT. CONCLUSION: THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    DURING THE REVIEW OF THE MAUDE ADVERSE EVENT DATABASE ON 06/08/2019, IT WAS DISCOVERED THAT A GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE WAS REFERENCED IN REPORT NUMBER 1835959-2018-00010 BY COOK BIOTECH INCORPORATED, DATED 09/12/2018. THE ADVERSE EVENT REPORT WAS IN REGARDS TO DEVICE CATALOG NUMBER ENT-OTO-2.5X2.5, BIODESIGN OTOLOGIC REPAIR GRAFT, WITH AN UNKNOWN LOT NUMBER. THE FOLLOWING EVENT WAS REPORTED BY COOK BIOTECH INCORPORATED: "DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. CONCOMITANT MEDICAL PRODUCTS: GRACE MEDICAL NOTCHED TITANIUM BUCKET HANDLE; GELFOAM. 510(K): K161000." "THE DOCTOR PERFORMED A STAPEDECTOMY IN A MALE PATIENT IN 2018. WHILE ELEVATING A FLAP, AN INCIDENTAL TEAR OCCURRED. A BIODESIGN OTOLOGIC REPAIR GRAFT WAS UTILIZED INSTEAD OF HARVESTING AN AUTOLOGIC GRAFT. GELFOAM WAS PLACED UNDER THE EAR DRUM. A GRACE MEDICAL NOTCHED TITANIUM BUCKET HANDLE WAS IMPLANTED TO REPLACE THE STAPES BONE. ONE WEEK POST-SURGERY, THE PATIENT PRESENTED WITH SEVERE EAR PAIN AND FACIAL PARALYSIS. THE PAIN AND PARALYSIS WERE UNRESPONSIVE TO STEROID TREATMENT. AT AN UNSPECIFIED TIME, THE PATIENT WENT BACK TO SURGERY. A GRANULOMA WAS FOUND AND EXCISED. THE GRANULOMA WAS IRRITATING A NERVE. POST GRANULOMA EXCISION, THE PATIENT REPORTEDLY HAD NO HEARING LOSS AND THE FACIAL PARALYSIS WAS IMPROVING. THE DOCTOR REPORTED ONLY SEEING ONE OTHER INSTANCE OF THIS OCCURRENCE IN THE LAST TWELVE YEARS. THE DOCTOR WAS UNCERTAIN IF THE BIODESIGN OTOLOGIC REPAIR GRAFT WAS RELATED TO THE OCCURRENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554032 GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT ETB GRACE MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENT-OTO-2.5X2.5, BIODESIGN OTOLOGIC REPAIR GRAFT| GELFOAM