BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® CERTAIN® 2 IMPLANT 5 X 11.5MM

    MDR report key: 3943635 · Received July 18, 2014

    Report

    Report Number
    0001038806-2014-00058
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 14, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK100724
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: UPON VISUAL INSPECTION, FOUND THAT THE INTERNAL HEX IN THE IMPLANT (XIFOSS510) HAD BEEN SLIGHTLY DAMAGED, BUT MATING COMPONENTS STILL FUNCTION WITHIN REQUIRED MANUFACTURING SPECIFICATION. NOT ENOUGH INFORMATION OR X-RAYS PROVIDED TO DETERMINE WHAT HAPPEN OR WHAT CAUSE FOR THE LINGUAL WALL FRACTURE. NO CONCLUSION CAN BE DRAWN. NOT DEVICE RELATED, POSSIBLE: CLINICAL / PATIENT RELATED. POTENTIAL ADVERSE EVENTS: POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF DENTAL IMPLANTS MAY INCLUDE: FAILURE TO INTEGRATE FRACTURE OF THE LINGUAL PLATE (IMPLANT IFU REV. C 02/2014).

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RETURNED, BUT THE EVALUATION HAS NOT YET BEEN STARTED.

    Description of Event or Problem · 1

    THE CLINICIAN INDICATED THAT IMPLANT PLACED ON (B)(6) 2013 AT TOOTH LOCATION #19 HAD FRACTURED THE LINGUAL WALL OF THE PATIENT'S MOUTH. THE CLINICIAN PLACED A GRAPH OVER THE FRACTURED SITE FOR IMPLANT REPLACEMENT AFTER 4 TO 6 MONTHS HEALING. THE CLINICIAN REPORTED THAT THERE WAS NO SERIOUS PATIENT INJURY, NO DETERIORATION IN PATIENT¿S HEALTH AND NO CONTRIBUTING CONDITIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422508 OSSEOTITE® CERTAIN® 2 IMPLANT 5 X 11.5MM OSSEOTITE® CERTAIN® 2 IMPLANT 5 X 11.5MM DZE BIOMET 3I N/A 2013060863

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention