BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    MDR report key: 9745179 · Received February 24, 2020

    Report

    Report Number
    0002023141-2020-00386
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    January 21, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017597
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL INFORMATION RECEIVED DURING FOLLOW UP IDENTIFIED THAT THERE IS NOT MALFUNCTION OR SERIOUS INJURY. THIS EVENT HAS BEEN DETERMINED TO BE NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS A CHIP FRACTURE AND THAT ANOTHER IMPLANT WAS PLACED DURING THE SURGERY.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K): K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED MANDIBLE BONE FRACTURE AT IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210324 IMPL TAPERED SP 4.8MM 8MM OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPWB8 2019051572 00889024017597

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention