BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL SCR-V HA 4.7MM 4.5MM 13MM

    MDR report key: 12829077 · Received November 17, 2021

    Report

    Report Number
    0002023141-2021-03301
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 20, 2021
    Report Date
    May 25, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: EXPIRATION DATE AND UDI NOT AVAILABLE. D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES.' G3: DATE RECEIVED BY THE MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES.' H4: DEVICE MANUFACTURE DATE NOT AVAILABLE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. DHR REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE DOCUMENT ASSOCIATED WITH THE LOT NUMBER REPORTED FOR PRODUCT SVWH13 IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT IS WITHIN SPECIFICATIONS. STERILIZATION RECORD REVIEW COULD NOT BE PERFORMED AS THE DHR FOR LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT IS WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2200499) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: PERI-IMPLANTITIS ) AND NO OTHER COMPLAINT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT: NOT PROVIDED. EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) NUMBER: UNKNOWN. FAX NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: ADDITIONAL NUMBERS: K011028 K013227. DEVICE MANUFACTURER DATE: UNKNOWN. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 5 WAS REMOVED DUE TO PERI-IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727819 IMPL SCR-V HA 4.7MM 4.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 2200499

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention