BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOHORIZONS INTERNAL IMPLANT SYSTEM

    MDR report key: 1616418 · Received February 23, 2010

    Report

    Report Number
    1060818-2010-00001
    Event Type
    Other
    Date Received
    February 23, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 24, 2010
    Manufacturer
    BIOHORIZONS, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE IMPLANT HAD NOT BEEN RETURNED TO BIOHORIZONS FOR EVAL, ALTHOUGH THE CLINICIAN REPORTED THAT HE PLANNED TO REMOVE THE IMPLANT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS ITEM AND LOT REVEALED NO ANOMALIES OR NONCONFORMANCES; ALL DOCUMENTATION REVIEWED INDICATED THAT THE IMPLANT HAD BEEN MANUFACTURED TO SPECIFICATIONS. AT THIS TIME, NO FURTHER CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PER CLINICIAN, IMPLANT FRACTURED IN SITU. RADIOGRAPHS WERE SUBMITTED SHOWING A FRACTURE OF THE IMPLANT COLLAR ABOVE THE THREADS ON ONE OF TWO IMPLANTS PLACED AT APPROX 30-45 DEGREES OUT OF PARALLEL IN THE POSTERIOR MOUTH REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHORIZONS INTERNAL IMPLANT SYSTEM ROOT-FORM DENTAL IMPLANT DZE BIOHORIZONS, INC. PYR3512 S0107006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other