BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)

    MDR report key: 7558480 · Received May 31, 2018

    Report

    Report Number
    0001038806-2018-00584
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    April 14, 2018
    Report Date
    October 8, 2018
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK092341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE LOW PROFILE ABUTMENT WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE ORIGINALLY REPORTED ILPC441U WAS A ILPC442U LOW PROFILE ABUTMENT INSTEAD VERIFIED THROUGH DRAWING 830061 REV A. THE VISUAL INSPECTION ALSO REVEALED THAT THE ABUTMENT FRACTURED AT THE APEX OF THE SEATING SURFACE. THE ALLEGED COMPLAINT IS THEREFORE CONFIRMED. 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 PRODUCTS IFU (P-IIS086GR) REV E. WARNINGS: MISHANDLING OF SMALL COMPONENTS INSIDE THE PATIENT¿S MOUTH CARRIES A RISK OF INGESTION, ASPIRATION AND/OR SWALLOWING. FRACTURE OF A RESTORATION MAY OCCUR WHEN AN ABUTMENT IS LOADED BEYOND ITS FUNCTIONAL CAPABILITY. REUSE OF BIOMET 3I PRODUCTS THAT ARE LABELED FOR SINGLE-USE MAY RESULT IN PRODUCT CONTAMINATION, PATIENT INFECTION AND/OR FAILURE OF THE DEVICE TO PERFORM AS INTENDED. PEEK COMPONENTS ARE INTENDED FOR USE TO SUPPORT SINGLEOR MULTIPLE-UNIT PROVISIONAL PROSTHESES IN THE MANDIBLE OR MAXILLA FOR UP TO 180 DAYS, AT WHICH TIME A DEFINITIVE PROSTHESIS SHOULD BE INSERTED. PRECAUTIONS: BIOMET 3I RESTORATIVE PRODUCTS SHOULD ONLY BE USED BY TRAINED PROFESSIONALS. THE SURGICAL AND RESTORATIVE TECHNIQUES REQUIRED TO PROPERLY UTILIZE THESE PRODUCTS ARE HIGHLY SPECIALIZED AND COMPLEX PROCEDURES. IMPROPER TECHNIQUE CAN LEAD TO IMPLANT FAILURE, LOSS OF SUPPORTING BONE, RESTORATION FRACTURE, SCREW LOOSENING, INGESTION AND ASPIRATION AND/OR SWALLOWING. COMPONENTS MADE FROM PEEK MATERIAL ARE INTENDED FOR USE FOR UP TO 180 DAYS. POTENTIAL ADVERSE EVENTS: POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF RESTORATIVE PRODUCTS MAY INCLUDE: FAILURE TO INTEGRATE; LOSS OF INTEGRATION; DEHISCENCE REQUIRING BONE GRAFTING; INFECTION AS REPORTED BY: ABSCESS, FISTULA, SUPPURATION, INFLAMMATION, RADIOLUCENCY; GINGIVAL HYPERPLASIA; EXCESSIVE BONE LOSS REQUIRING INTERVENTION; FRACTURE; INGESTION, ASPIRATION AND/OR SWALLOWING AND NERVE INJURY. A SINGULAR CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREW PORTION OF THE LOW PROFILE ABUTMENT (ILPC442U) FRACTURED. THE FRACTURED SCREW PORTIONS WERE ABLE TO BE REMOVED FROM THE IMPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW PORTION OF THE LOW PROFILE ABUTMENT (ILPC441U) FRACTURED. THE FRACTURED SCREW PORTIONS WERE ABLE TO BE REMOVED FROM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401111 CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) LOW PROFILE DENTAL ABUTMENT NHA BIOMET 3I 2016061946

    Patients

    Seq Age Sex Outcome Treatment
    1