BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7, 8, MTXF, MG, HA

    MDR report key: 12360523 · Received August 24, 2021

    Report

    Report Number
    0002023141-2021-02281
    Event Type
    Injury
    Date Received
    August 24, 2021
    Report Date
    January 11, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344389
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4310. ONE IMP, TSV, 4.7, 8, MTXF, MG, HA (TSVTWH8) IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO APPARENT MALFUNCTION. SIGNS OF USE. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURES (RELOCATED TO SINUS) AS IT IS MEDICAL EVENT. HOWEVER, MEASUREMENTS WERE TAKEN USING A CALIPER. PRE-EXISTING PATIENT CONDITION NOTED ON THE PER WAS PARKINSONS. THE REPORTED DEVICE WAS BEING PLACED ON TOOTH #UNK FOR ABOUT 7 MONTHS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. PER THE APPLICABLE IFU, UNDER SECTION WARNINGS, IT IS STATED THAT IMPROPER TECHNIQUES CAN CAUSE BONE LOSS, PATIENT INJURY, PAIN AND IMPLANT FAILURE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230038. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW BY LOT NUMBER (1230038) WAS PERFORMED FOR SIMILAR EVENT (KEYWORD CATEGORY: PERFORATED SINUS, RELOCATED TO SINUS, PERFORATED SINUS) AND NO OTHER SIMILAR COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR PRODUCT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION AND RISK FILE REVIEW, THE MOST LIKELY CAUSE IS CUSTOMER ERROR IN SURGICAL SITE PREPARATION BASED ON IMPLANT SIZE. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED SINCE IT WAS A MEDICAL CONDITION AND NO X-RAY OR PICTORIAL EVIDENCE WAS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS AND FAX NUMBER UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K133339. 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 IMPLANT MIGRATED INTO THE MAXILLARY SINUS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION TOOTH LOCATION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257652 IMP, TSV, 4.7, 8, MTXF, MG, HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWH8 1230038 00889024344389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention