BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM

    MDR report key: 18993751 · Received March 28, 2024

    Report

    Report Number
    0002023141-2024-00964
    Event Type
    Injury
    Date Received
    March 28, 2024
    Report Date
    August 25, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019393
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4310. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. THE IMPLANT WAS IDENTIFIED AS REPORTED HOWEVER, NO APPARENT MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. IMPLANT MATCHED PRINTS WHERE MEASURED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1252053. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1252053 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. PER THE APPLICABLE IFU, IMPROPER TECHNIQUES CAN CAUSE BONE LOSS, PATIENT INJURY, PAIN AND IMPLANT FAILURE. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE CUSTOMER ERROR ¿ IMPROPER TECHNIQUES USED DURING PLACEMENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS NON-VERIFIABLE WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. E1: LAST/GIVEN NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K011028 / K013227. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED PAIN AROUND THE IMPLANT AT TOOTH LOCATION #19. THE IMPLANT WAS REMOVED AND REPLACED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724691 IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 1252053 00889024019393

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention