BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 16657013 · Received March 31, 2023

    Report

    Report Number
    0002023141-2023-00958
    Event Type
    Injury
    Date Received
    March 31, 2023
    Date of Event
    February 9, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE COMPLAINT REPORTED THAT AN INTERN SINUS LIFT AT TOOTH SITE 24 WAS PERFORMED. WHEN PLACING THE IMPLANT THERE WAS A BONE SPLITTING AND IMPLANT HAD TO BE REMOVED DUE TO PERFORATED SINUS. AFTER PROCEDURE, DOCTOR PLACED BONE GRAFT AND PERFORMED PLASTIC COVERING. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT. ONE TAPERED SCREW-VENT IMPLANT, (TSVB10) WAS RETURNED FOR EVALUATION. VISUAL/PHYSICAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THAT NATURE OF THE DEVICE AND EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1253295. 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 1253295 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: BONE FRACTURE & PERFORATED SINUS. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS, IFU4869 REV 9 - 10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND BREAKAGE. PER THE APPLICABLE IFU, ZIMMER DENTAL IMPLANTS SHOULD NOT BE PLACED IF THERE IS AN INSUFFICIENT VOLUME OF ALVEOLAR BONE TO MINIMALLY SUPPORT THE IMPLANT (MINIMUM 1MM CIRCUMFERENTIAL AND 2MM APICAL). IMPLANTS PLACED IN THE MAXILLA SHOULD NOT PERFORATE THE SINUS FLOOR MEMBRANE. POOR BONE QUALITY, POOR PATIENT ORAL HYGIENE, HEAVY TOBACCO USE, UNCONTROLLED SYSTEMATIC DISEASES (DIABETES, ETC.), REDUCED IMMUNITY, ALCOHOLISM, DRUG ADDICTION, AND PSYCHOLOGICAL INSTABILITY MAY CONTRIBUTE TO LACK OF INTEGRATION AND/OR SUBSEQUENT IMPLANT FAILURE. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS PLACEMENT OF IMPLANT IN A PATIENT WITH POOR ORAL HYGIENE OR PARAFUNCTIONAL HABITS INCOMPATIBLE WITH LONG-TERM OSSEOINTEGRATION OF IMPLANT ¿ IMPROPER TECHNIQUES USED IN POOR BONE QUALITY. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE UNKNOWN/UNVERIFIABLE. 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER: UNKNOWN / NOT PROVIDED. AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED. REPORTER NAME AND ADDRESS: UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT AN INTERN SINUS LIFT AT TOOTH SITE 24 WAS PERFORMED. WHEN PLACING THE IMPLANT THERE WAS A BONE SPLITTING AND IMPLANT HAD TO BE REMOVED DUE TO PERFORATED SINUS. AFTER PROCEDURE, DOCTOR PLACED BONE GRAFT AND PERFORMED PLASTIC COVERING. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425353 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1253295 00889024019508

    Patients

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