BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM

    MDR report key: 10351996 · Received July 31, 2020

    Report

    Report Number
    0002023141-2020-01161
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    May 21, 2018
    Report Date
    October 5, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: LOT/SERIAL . D4: DEVICE EXPIRATION DATE . D4: DEVICE UDI NUMBER . G4: DATE RECEIVED BY MANUFACTURER. G5: K013227. G7: CHECKED "FOLLOW-UP" . H2: CHECKED FOLLOW-UP TYPE. H4: DEVICE MANUFACTURER DATE . H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT NOT PROVIDED/UNKNOWN. DEVICE LOT NUMBER NOT PROVIDED/UNKNOWN. REPORTER'S NAME UNKNOWN. ADDITIONAL 510K NUMBER: K013227. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR LACK OF PRIMARY STABILITY EVENTS THAT DO NOT ALLEGE A DEFICIENCY WITH THE IMPLANT AND IDENTIFIED THAT THE REPORTED EVENT IS LIKELY DUE TO BIOLOGICAL FACTORS WHICH HAVE AN ADVERSE EFFECT ON IMPLANT STABILITY OR IS RELATED TO SURGICAL TECHNIQUE AND INSERTION TORQUE. DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN/ NON-MANUFACTURING RELATED), IDENTIFYING A DEFINITIVE ROOT CAUSE IS GENERALLY NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACED INTO OSTEOTOMY. ANOTHER IMPLANT WAS NOT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815773 IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 63750139

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention