BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV, 4.1,11, MTX,MC,M

    MDR report key: 12480193 · Received September 16, 2021

    Report

    Report Number
    0002023141-2021-02582
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 19, 2021
    Report Date
    February 8, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344006
    PMA / PMN Number
    K133339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST
    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: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. ONE IMP, TSV, 4.1,11, MTX, MC, M (TSVM4H11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE (BONE RESIDUE) BUT NO APPARENT SIGNS OF MALFUNCTION. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENT (PERFORATED SINUS). HOWEVER, MEASUREMENTS WERE TAKEN USING A CALIPER. FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATION. THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE NON-VERIFIABLE. BASED ON THE EVALUATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION HAS NOT OCCURRED. THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE EVENTS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW FOR THE LOT (1241846) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241846) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: PERFORATED SINUS) AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION ARE IMPROPER TECHNIQUES USED DURING PLACEMENT/SEATING ¿ PLACING IMPLANT OF INAPPROPRIATE SIZE (DIAMETER, LENGTH) LEADING TO PUNCTURING OR THE SINUS CAVITY OR COMPRESSION OF THE MANDIBULAR NERVE. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH: UNKNOWN / NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT THE APEX OF THE DENTAL IMPLANT PERFORATED THE FLOOR OF THE SINUS. THE IMPLANT WAS REMOVED. PATIENT WILL RETURN IN 4 MONTHS FOR US TO TEST THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377502 IMP,TSV, 4.1,11, MTX,MC,M DENTAL IMPLANT DZE ZIMMER DENTAL TSVM4H11 1241846 00889024344006

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention