BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® UCLA GOLD NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. GOLD-TITE® SCREW

    MDR report key: 6568370 · Received May 15, 2017

    Report

    Report Number
    0001038806-2017-00231
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    May 13, 2015
    Report Date
    July 28, 2017
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE SCREW PORTION OF THE ABUTMENT BUNDLE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    A LARGE DIAMETER GOLD-TITE SCREW (ILRGHG) WERE RETURNED. THE CERTAIN® UCLA GOLD NON-HEXED ABUTMENT WAS NOT RETURNED. VISUAL INSPECTION OF THE AS RECEIVED PRODUCTS IDENTIFIED WEAR AND DISCOLORATION AROUND THE SHANKS AND THE THREADS OF BOTH THE SCREWS. THERE WAS NOTICEABLE GOUGING AROUND THE HEX CIRCUMFERENCE. THE HEXES IDENTIFIED GENERAL SINGS OF USAGE BUT HAD NO EVIDENCE OF ANY DAMAGE. THE X-RAY PROVIDED DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MALFUNCTION THAT WOULD HAVE CAUSE OR CONTRIBUTED TO THE REPORTED LOOSENING. THE DHR REVIEW DID NOT PROVIDE ANY DEVIATIONS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE COMPLAINT HISTORY REVIEW FOR LOT NUMBER 960742-5 CONCLUDED THAT THERE ARE NO OTHER COMPLAINTS REPORTED AGAINST THE SUBJECT LOT TO DATE. DOCUMENT TYPE(S) REVIEWED: BIOMET 3I RESTORATIVE MANUAL, INSTRM REV B 10/15. INFORMATION IDENTIFIED: INSTRUCTIONS FOR USE OF THE RECOMMENDED RESTORATION ARE PROVIDED ALONG WITH THE APPROPRIATE TORQUE VALUES. BIOMET 3I RESTORATIVE IFU (INSTRUCTIONS FOR USE) P-IIS086GR REV. E 11/2015. 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. 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. THE COMPLAINT WAS NOT VERIFIABLE, AS THE EVENT IS REFERRING TO LOOSENING AND THE EXACT DETAILS OF THE DEVICE USAGE WERE UNKNOWN AND COULD NOT BE REPLICATED. THERE WERE GENERAL SIGNS OF WEAR AROUND THE SCREW BUT NO EVIDENCE OF ANY MALFUNCTION OR MAJOR DAMAGE TO THE THREADS OR THE HEX THAT WOULD HAVE CONTRIBUTED TO THE LOOSENING EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR INDICATED THE CERTAIN® UCLA GOLD NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. GOLD-TITE® SCREW CONTINUES TO LOOSEN. THE PROSTHESIS WAS PLACED ON (B)(6) 2012 AND WORKED NORMALLY UNTIL (B)(6) 2015 WHEN IT WAS FOUND LOOSENED, THE DOCTOR TRIED TO RETIGHTEN AND IT LOOSENED AGAIN ON (B)(6) 2016, (B)(6) 2017. THE DOCTOR REPORTS THAT THE ABUTMENT SCREWS WERE REPLACED AND THE PROSTHESES IS PREFORMING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349203 CERTAIN® UCLA GOLD NON-HEXED ABUTMENT 3.4MM(D) W/LARGE DIA. GOLD-TITE® SCREW ABUTMENT AND ABUTMENT SCREW NHA BIOMET 3I 960742-5

    Patients

    Seq Age Sex Outcome Treatment
    1