BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR REPLACE FRICTION-FIT GOLD & TI ABUT INT HEX

    MDR report key: 22129307 · Received June 2, 2025

    Report

    Report Number
    0002023141-2025-01483
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    April 23, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K953101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) MHLAS, (SCR REPLACE FRICTION-FIT GOLD & TI ABUT INT HEX) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. RETURNED SCREW SHOWS SIGNS OF WEAR/USE. SOME DAMAGE CAN BE OBSERVED AROUND ITS DRIVE FEATURE AND SOME WEAR AROUND ITS THREADS LIKELY CAUSED DURING REMOVAL. TESTED WITH IN-HOUSE IMPLANT AND IT THREADS WITH DIFFICULTY. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER ASSOCIATED TO THE ITEM WAS NOT PROVIDED. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER MHLAS FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : LOOSENING¿. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER (B)(4), THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS POSSIBLY USER CAUSED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. THE RETURNED SCREW SHOWED SOME DAMAGE LIKELY CAUSED DURING REMOVAL. HOWEVER, THE REPORTED LOOSENING EVENT IS NON-VERIFIABLE. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MHLAS SCREW WAS WOBBLY/LOOSE. CROWN RETENTION SCREW LOST ENGAGEMENT IN CROWN. CLINICIAN REMOVED THAT MHLAS & PLACED A NEW ONE. REPLACED THE SCREW AND THE CROWN TORQUED DOWN TO 25 NEWTONS. CROWN WAS MOBILE WITH THE OLD SCREW TORQUED INTO PLACE. WHEN THE NEW ONE PLACED IT WAS PERFECT WAS NOT LOOSE NOR WOBBLY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA & INFLAMMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065305 SCR REPLACE FRICTION-FIT GOLD & TI ABUT INT HEX DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown