BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT

    MDR report key: 4409541 · Received January 12, 2015

    Report

    Report Number
    0001038806-2014-00188
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Report Date
    December 17, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK052648
    Removal / Correction Number
    Z-1215-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER REPORTED THE COMPLAINT WITH REFERENCE TO AN EDAX, LOT 1063189. HOWEVER, THE PRODUCT RETURNED WAS AN EDAZX. A REVIEW OF THE ORDER HISTORY FOR THE CUSTOMER IDENTIFIED LOT 1053014 AS THE POTENTIALLY CORRECT LOT NUMBER. THE CORRECT LOT NUMBER COULD NOT BE VERIFIED THROUGH CONTACT WITH THE CUSTOMER. THEREFORE AN INVESTIGATION OF BOTH LOTS WAS COMPLETED. AS IT IS MORE LIKELY THAT THE CUSTOMER RECORDED THE INCORRECT ITEM AND LOT INFORMATION FOR THIS PARTICULAR PATIENT RATHER THAN SENT THE WRONG FRACTURED ABUTMENT, THE ITEM AND LOT NUMBER ARE EDAZX, LOT 1053014. INVESTIGATION OF OTHER COMPLAINTS WITH SIMILAR ABUTMENTS THAT WERE FRACTURED CONCLUDED THE FRACTURE WAS RELATED TO THE DESIGN OF THE HEX AND BOSS CONNECTION AND TO THE SCREW ACCESS HOLE WHICH LED TO THE RECALL.

    Description of Event or Problem · 1

    DR. INDICATED THE ZIRCONIA ABUTMENT FRACTURED IN THE PATIENT¿S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26711 BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT ZIRCONIA ABUTMENT NHA BIOMET 3I N/A 1053014

    Patients

    Seq Age Sex Outcome Treatment
    1