BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL SCREW

    MDR report key: 12535888 · Received September 27, 2021

    Report

    Report Number
    0001038806-2021-01827
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Report Date
    February 17, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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: 4110 AND 4114. H10: NARRATIVE/DATA WAS UPDATED. ONE (1) UNKNOWN 3I SCREW WAS NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE APPLICABLE INSTRUCTIONS FOR USE (IFU), RISK FILES, AND PATIENT X-RAYS. THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT WAS CONFIRMED FOLLOWING X-RAY EVALUATION. BASED ON THE EVALUATION, THE REPORTED MALFUNCTION HAS OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICES. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATION AND CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED SINCE, THE LOT/ITEM NUMBERS WERE NOT PROVIDED. HOWEVER, ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE, THE PRODUCT WAS NOT RETURNED. THEREFORE, THE REPORTED EVENT COULDN'T BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE PROBABLE CAUSE FOR THE REPORTED EVENT IS IMPROPER TECHNIQUES USED OR PLACEMENT OF DEVICES IN A PATIENT WITH PATIENT FACTORS INCOMPATIBLE WITH LONG-TERM OSSEO-INTEGRATION OF IMPLANT. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THE 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. BRAND NAME UNKNOWN / NOT PROVIDED. CATALOG AND LOT NUMBER UNKNOWN / NOT PROVIDED. CONCOMITANT MEDICAL PRODUCT-UNKNOWN 3I BIOMET IMPLANT, LOT# UNKNOWN. THERAPY DATE- UNKNOWN. PMA/510(K) NUMBER NOT AVAILABLE. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DOCTOR PLACED AN IMPLANT AT SITE #13. THIS IMPLANT WAS RESTORED AS A SPLINTED CROWN WITH IMPLANT #12. THE DOCTOR RECEIVED A CALL FROM THE RESTORING DENTIST IN JULY OF THIS YEAR STATING THAT IMPLANT #13 HAS A BROKEN SCREW AND THAT THEY "DRILLED OUT AS MUCH AS THEY COULD OF THE BROKEN SCREW". THE PATIENT WAS BEING REFERRED TO THE SURGEON IN HOPES TO REMOVE THE REMAINDER OF THE BROKEN SCREW. THE DOCTOR SAW THE PATIENT AND USED A BROKEN SCREW EXTRACTION KIT FROM RHEIN MADE FOR THIS IMPLANT DIAMETER SIZE AND MAKE. THE DOCTOR WAS NOT ABLE TO RETRIEVE THE BROKEN SCREW IN THIS CASE. THE DOCTOR ALSO USED A CAVITRON ON THE BROKEN SCREW. THE PATIENT RETURNED ON A LATER DATE AND THEY USED THE BIOMET EXTRACTION KIT FOR THIS MAKE AND DIAMETER OF IMPLANT AND WAS NOT SUCCESSFUL IN REMOVING THE BROKEN SCREW. THE CUSTOMER SERVICE REP REPORTS THAT THE SCREW MAY BE TOO DEEP FOR RETRIEVAL BUT NO ADDITIONAL DETAILS HAVE BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429479 DENTAL SCREW NHA BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DENTAL IMPLANT-SEE H10 NARRATIVE