BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL OSSEOTITE® IMPLANT 4 X 13MM

    MDR report key: 3780956 · Received April 30, 2014

    Report

    Report Number
    0001038806-2014-00037
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    PK063286
    Removal / Correction Number
    K063286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: UPON VISUAL INSPECTION, FOUND THAT THIS IMPLANT HAS FRACTURED. LIKELY CAUSE: IN THE ABSENCE OF ANY PROCESS OR MATERIAL RELATED CAUSE, THE MOST LIKELY CAUSE OF THE FRACTURE IS RELATED TO BIO-MECHANICAL OVERLOAD. CHECKED INVENTORY AND ALL (B)(4)/ FOS413 FROM THIS LOT HAVE BEEN SHIPPED AND THIS IS THE ONLY FRACTURE AND 9TH COMPLAINT TO DATE. OTHER INCIDENTS WERE FOR LOSS / NON-INTEGRATION. THE REVIEW OF THE DHR RECORDS DID NOT PROVIDE ANY INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CAUSE THIS CONDITION.

    Additional Manufacturer Narrative · 1

    THE SWALLOWED PORTION OF THE IMPLANT WILL NOT BE RETURNED FOR EVALUATION. THE FRACTURED PORTION OF IMPLANT THAT REMAINED IMPLANTED HAS BEEN REMOVED AND EVALUATION OF THAT FRACTURE IS IN PROGRESS. THE EVENT OF INGESTION ISN¿T LIKELY TO CAUSE DEATH OR SERIOUS INJURY BECAUSE A FRACTURE DENTAL IMPLANT IS SMALL AND CYLINDRICAL AND IS ANTICIPATED TO PASS THROUGH THE DIGESTIVE TRACK WITHOUT REQUIRING MEDICAL OR SURGICAL INTERVENTIONS AND WITHOUT SEQUELAE. HOWEVER, THIS EVENT IS REPORTABLE AS A SERIOUS INJURY DUE TO THE SURGICAL/MEDICAL INTERVENTION REQUIRED TO PRECLUDE/RESOLVE ISSUES ASSOCIATED WITH THE FRACTURED IMPLANT. MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE DID NOT OCCUR. HOWEVER, IN AN ABUNDANCE OF CAUTION, A MDR IS BEING FILED AS IT IS RECOGNIZED THAT THE POSSIBILITY EXISTS THAT THE INGESTION OF CERTAIN DEVICES AND/OR THE INGESTION OF CERTAIN DEVICES BY INDIVIDUALS WITH CERTAIN HEALTH CONDITIONS MAY INCREASE THE LIKELIHOOD THAT DEATH, SERIOUS INJURY OR MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE MAY OCCUR.

    Description of Event or Problem · 1

    A PATIENT REPORTED TO HIS DENTIST THAT ABOUT A MONTH EARLIER HE EXPERIENCED A FRACTURE OF HIS DENTAL IMPLANT. THE PATIENT REPORTED THAT HE BELIEVES HE SWALLOWED THE CROWN BECAUSE HE WAS UNABLE TO LOCATE THE CROWN. HE BELIEVES THAT HE PASSED THE CROWN NATURALLY. THE PATIENT REPORTED THAT HE HAS NO OTHER ISSUES WITH THE IMPLANT AND IS IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260405 FULL OSSEOTITE® IMPLANT 4 X 13MM FULL OSSEOTITE® IMPLANT 4 X 13MM DZE BIOMET 3I N/A 2010101779

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other