BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS

    MDR report key: 11086549 · Received December 29, 2020

    Report

    Report Number
    1045254-2020-00657
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 29, 2020
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    FZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: XOM UNK PROSTHESIS, SERIAL/LOT #: NI, (B)(4). OUTCOMES USING DIFFERENT MATERIALS IN THE TREATMENT OF CHRONIC OTITIS MEDIA" OTOLOGY <(>&<)> NEUROTOLOGY, INC., 41:1-6, 2020, DOI: 10.1097/MAO.0000000000002847. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: THIS STUDY AIMED TO EVALUATE SUCCESS RATES AFTER OSSICULAR CHAIN RECONSTRUCTION USING DIFFERENT MATERIALS. HEARING DATA WERE MEASURED 1 DAY PREOPERATIVELY AND 6 MONTHS POSTOPERATIVELY. SUCCESSFUL HEARING OUTCOMES WERE DEFINED BY THE FULFILLMENT OF MORE THAN ONE OF THE FOLLOWING CRITERIA: POSTOPERATIVE AIR¿BONE GAP OF 20 DB OR LESS, HEARING AIR CONDUCTION (AC) GAIN OF 15 DB OR MORE, OR POSTOPERATIVE AC HEARING LESS THAN 30 DB. PREOPERATIVE MEDIAN AC VALUES (95% CONFIDENCE INTERVAL) AMONG PARTICIPANTS WITH MALLEUS, INCUS, CORTICAL BONE, HA, AND TITANIUM TRANSPLANTS OR PROSTHESES WERE 50 (39.6¿54.6) DB, 51.3 (48.1¿51.8) DB, 50 (45.2¿52.2) DB, 56.3 (50.9¿57.6) DB, AND 54.3 (48.5¿56.0) DB, RESPECTIVELY ( P ¼ 0.092). THE SUCCESS RATES IN MALLEUS, INCUS, CORTICAL BONE, HA, AND TITANIUM WERE 53.3%, 60.3%, 51.7%, 61.6%, AND 69.7%, RESPECTIVELY. TITANIUM HAD THE HIGHEST SUCCESS RATE AMONG THE FIVE MATERIALS, BUT THE DIFFERENCES BETWEEN THE MATERIALS WERE NOT STATISTICALLY SIGNIFICANT ( P¼0.283). TITANIUM HAD HIGHEST SUCCESS RATE AMONG THE PARTICIPANTS WITH EROSIVE STAPES SUPRASTRUCTURE OR OBSTRUCTED EUSTACHIAN TUBES ( P¼0.042 FOR EROSIVE STAPES SUPRASTRUCTURE AND P¼0.010 FOR OBSTRUCTED EUSTACHIAN TUBES). CONCLUSION: OUR STUDY DEMONSTRATED THAT TITANIUM PROSTHESES WOULD BE A GOOD ALTERNATIVE FOR OSSICULOPLASTY IN CASES WHEREIN AUTOLOGOUS MATERIAL IS UNAVAILABLE, ESPECIALLY IN ASSOCIATION WITH UNFAVORABLE CONDITIONS, SUCH AS WITH THE PRESENCE OF CHOLESTEATOMA, EROSIVE STAPES SUPRASTRUCTURE, EDEMATOUS MIDDLE EAR MUCOSA, AND OBSTRUCTED EUSTACHIAN TUBE. REPORTED EVENT(S): THERE WAS ONE INSTANCE OF PERFORATION OCCURRED IN A PATIENT USING TITANIUM PROSTHESES. THERE WERE FOUR INSTANCE OF PERFORATION OCCURRED IN PATIENTS USING HA PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557528 PROSTHESIS FZD MEDTRONIC XOMED INC. XOM UNK PROSTHESIS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other