BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL SCREW

    MDR report key: 12829257 · Received November 17, 2021

    Report

    Report Number
    0002023141-2021-03304
    Event Type
    Injury
    Date Received
    November 17, 2021
    Report Date
    May 5, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: 4110 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3252. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ONE IMP,TSV,MCOL MG,4.1MM,10M, TSVM4B10 WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE PRODUCT IDENTIFIED BONE/TISSUE ATTACHED TO THE IMPLANT EXTERNAL THREADS. FRACTURED PORTION OF UNKNOWN SCREW IDENTIFIED WITHIN THE IMPLANT. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION HAS OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS AGAINST THE REPORTED DEVICES THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241987). 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. DHR REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED UNKNOWN SCREW IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241987) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE IMPLANT/SCREW) AND REVEALED NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT. A COMPLAINT HISTORY REVIEW FOR THE UNKNOWN ZB SCREW COULD NOT BE PERFORMED AS THE LOT/ITEM NUMBERS WERE UNKNOWN. THE REPORTED EVENT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE AND CANNOT BE RECREATED DUE TO THE NATURE OF THE ALLEGED EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION ARE USE OF IMPLANT OUTSIDE OF INTENDED USE OR PARAFUNCTIONAL HABITS THE PATIENT (E.G. CLENCHING, BRUXISM AND OVERLOADING). 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). WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. BRAND NAME UNKNOWN / NOT PROVIDED. CATALOG AND LOT NUMBER UNKNOWN / NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS:: TSVM4B10, IMP,TSV,MCOL MG,4.1MM,10M, LOT# 1241987. FAX NUMBER UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER NOT AVAILABLE. 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 AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO FRACTURED SCREW BEING IRRETRIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729520 DENTAL SCREW NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention DENTAL IMPLANT.