BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTOMIMIX CALCIUM PHOSPHATE BONE VOID FILLER 2 GRAMS

    MDR report key: 7337777 · Received March 14, 2018

    Report

    Report Number
    0001032347-2018-00122
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    October 12, 2017
    Report Date
    August 30, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    NEA
    PMA / PMN Number
    PK042516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UNIQUE IDENTIFIER (UDI) # (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. FOR THIS REASON, THE COMPLAINT COULD NOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE SECTION TITLED WARNINGS: IMPROPER PLACEMENT AND POSITIONING OF THE FILLER CAN CAUSE A SUBSEQUENT UNDESIRABLE RESULT THE SURGEON MUST BE FAMILIAR WITH THE MATERIAL PROPERTIES, HANDLING CHARACTERISTICS, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY. THE IFU ALSO PROVIDES INSTRUCTIONS AND APPROPRIATE MIXING TIMES IN THE SECTIONS TITLED MIXING INSTRUCTIONS AND PRODUCT MIXING TIMES. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). REPORT SOURCE: FOREIGN COUNTRY (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN OSSICULOPLASTY PROCEDURE THE FIRST BATCH OF OTOMIMIX (LOT 211240) WOULD NOT MIX WELL AT ALL AND TOOK AROUND TWO-THREE (2-3) MINUTES TO TURN TO A DOUGH LIKE CONSISTENCY. THIS BATCH WAS PLACED IN THE EAR AND AFTER TWENTY (20) MINUTES IT HAD NOT SET. THIS BATCH WAS THEN REMOVED AS IT WAS NOT WORKING AS EXPECTED. A SAMPLE OTOMIMIX THAT HAD PREVIOUSLY BEEN PROVIDED (LOT 392710) WAS MIXED AND WORKED CORRECTLY. THE FIELD WAS CLEANED AND DRIED AS MUCH AS POSSIBLE BEFORE THE CEMENT WAS USED THIS TIME. NO ISSUES OCCURRED AND THE CEMENT SET WITHIN FIVE (5) MINUTES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180312 OTOMIMIX CALCIUM PHOSPHATE BONE VOID FILLER 2 GRAMS BONE VOID FILLER NEA BIOMET MICROFIXATION N/A 211240

    Patients

    Seq Age Sex Outcome Treatment
    1