BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    MDR report key: 16482383 · Received March 3, 2023

    Report

    Report Number
    0002023141-2023-00714
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 11, 2023
    Report Date
    July 25, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017597
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED . LOT/SERIAL # UNKNOWN / NOT PROVIDED . DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. DEVICE UDI NUMBER UNKNOWN / NOT PROVIDED. K011245, K002188. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION K082639/K011245/K002188. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2022051095. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. STERILIZATION RECORD (B)(4) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 2022051095 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: MEDICAL: PERI-IMPLANTITIS¿. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    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 D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H4: DEVICE MANUFACTURER DATE H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 20 WAS REMOVED DUE TO PERI-IMPLANTITIS. EDEMA AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. NO DELAY, PROCEDURE WAS NOT COMPLETED AND PATIENT WILL NOT HAVE TO RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 35 WAS REMOVED DUE TO PERI-IMPLANTITIS. EDEMA AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. NO DELAY, PROCEDURE WAS NOT COMPLETED AND PATIENT WILL NOT HAVE TO RETURN.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001423 IMPL TAPERED SP 4.8MM 8MM OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPWB8 2022051095 00889024017597

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention