BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 4.8MM 14M M OCTAGON

    MDR report key: 13313466 · Received January 21, 2022

    Report

    Report Number
    0002023141-2022-00132
    Event Type
    Injury
    Date Received
    January 21, 2022
    Report Date
    May 11, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER: K011245 AND K002188. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4) THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT B5: DESCRIBE EVENT OR PROBLEM D4: CATALOG D4: LOT NUMBER UPDATED TO UNKNOWN D4: EXPIRATION DATE AND UDI NOT AVAILABLE, LOT NUMBER UNKNOWN G3: DATE RECEIVED BY THE MANUFACTURER G4: PMA/510(K) NUMBER K011245 AND K002188 H1: TYPE OF REPORT, FOLLOW-UP NUMBER H2: FOLLOW UP TYPE H4: DEVICE MANUFACTURE DATE NOT AVAILABLE, LOT NUMBER UNKNOWN H6: EVALUATION CODES H10: ADDITIONAL NARRATIVE UPON ONGOING INVESTIGATION IT WAS IDENTIFIED THAT THE IMPLANT RECEIVED DOES NOT CORRESPOND TO IMPLANT REPORTED ON MFR-0002023141-2022-00132 THEREFORE THIS REPORT IS INTENDED TO UPDATE REFERENCE. H3 OTHER TEXT : SUMMARY INVESTIGATION

    Description of Event or Problem · 0

    IT WAS REPORTED IMPANT REMOVED DUE TO INFECTION AND PAIN.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857679 IMPL TAPERED SP 4.8MM 14M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 62147585

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention