BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN HEX.TRY-IN SCREW 5 UN

    MDR report key: 6554385 · Received May 9, 2017

    Report

    Report Number
    0001038806-2017-00208
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    April 7, 2017
    Report Date
    July 25, 2017
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    PK072642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER IS UNKNOWN/NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    ONE CERTAIN® TITANIUM HEXED TRY-IN SCREW WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE SCREW WAS FRACTURED AT THE TOP OF THE DRIVE HEAD. THE HEAD HAS SHEARED OFF IN A RING AROUND THE TOP OF THE SCREW. THE DRIVE FEATURE IS WORN AND STRIPPED. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: BIOMET 3I RESTORATIVE MANUAL INSTRM REV C 09/16 THE BIOMET 3I RESTORATIVE MANUAL WAS CONFIRMED TO CONTAIN INSTRUCTION ON SCREW PLACEMENT AS WELL AS RECOMMENDED TORQUE VALUES. IN THE CASE OF CERTAIN® TITANIUM HEXED TRY-IN SCREW IT IS RECOMMENDED THAT THE SCREW IS HAND TIGHTENED, AND THAT THE PRODUCT IS NOT MEANT FOR RETAINED FIXATION. RISKS RELATED TO THIS EVENT ARE HIGHLIGHTED IN RM-00057-HAZ REV 2, WHICH CALLS OUT "INADEQUATE TREATMENT PLANNING, MISUNDERSTOOD OR OVERLOOKED INSTRUCTIONS FOR USE" LEADING TO SCREW FRACTURE. THE PROBABLE CAUSE FOR THIS COMPLAINT CAN BE DETERMINED BASED ON MISUSE AND A BREACH IN RESTORATIVE PROTOCOL. IT IS STATED IN THE ¿BIOMET 3I RESTORATIVE MANUAL CATRM¿ REV. B 10/06 THAT TRY-IN SCREWS ARE MEANT FOR USE WITH AN ANALOG, AND NOT WITH A SURGICAL SITE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTS THAT THE PATIENT PRESENTED WITH LOOSE RESTORATION WITH TOOTH (B)(6). THE ABUTMENT SCREW (IUNIHT) WAS FOUND TO BE FRACTURED. THE DOCTOR HAD TO REMOVE SOFT TISSUE FROM THE SITE AND SCREW DOWN THE RESTORATION AGAIN. THE DOCTOR REPORTS THAT THE IMPLANT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335955 CERTAIN HEX.TRY-IN SCREW 5 UN ABUTMENT TRY-IN SCREW NDP BIOMET 3I IUNITS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IEDAT5