BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H)

    MDR report key: 3951221 · Received July 22, 2014

    Report

    Report Number
    0001038806-2014-00087
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PD004657
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION. BASED UPON CLINICAL INPUT FROM POST MARKET CLINICAL ADMINISTRATOR AND CONSULTING CLINICIAN: THIS WOULD BE A REPORTABLE EVENT DUE TO THE FACT THAT THE CLINICIAN WOULD HAVE AN INCOMPATIBLE HEALING ABUTMENT FOR THE IMPLANT THAT WAS PLACED AND THERE IS A POTENTIAL THAT THE CLINICIAN MAY NOT HAVE AN REPLACEMENT HEALING ABUTMENT FOR THE PROCEDURE, WHICH COULD REQUIRE AN ADDITION SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: PACKAGE WAS VISUALLY INSPECTED. PACKAGE WAS NOT RECEIVED SEALED (OPENED). IT CONTAINED INCORRECT PRODUCT INSIDE (IWTH53 AS IN THE COMPLAINT SUBJECT). THE PRODUCT INSIDE THE PACKAGE IS INDEED ISWHA53, THE LABEL OF RETURNED PACKAGE WAS SCANNED WITH BAR CODE SCANNER AND THE INFORMATION OF LOT AND REF. WAS CONSISTENT. FINISHED GOODS (FG) FOR WTH53 (LOT# 1166681) WERE REVIEWED FOR ANY ON HAND QUANTITY AND NONE WAS FOUND. NC HISTORY FOR THE LOT ABOVE WAS ACCESSED AND NO NON-CONFORMANCE WAS FOUND TO THIS DATE. COMPLAINT HISTORY FOR WTH53 SEARCHED IN ETQ BY PRODUCT NAME AND REVEALED NO COMPLAINTS RELATED TO MIX-UP. DHR FOR ISWHA 53, LOT# 1167301 ((B)(6) 2013- (B)(6) 2013) AND LOT# 1165562 ((B)(6) 2013- (B)(6) 2013) WAS REVIEWED FOR ANY SCRAP IN PARTS AND LABELS. NO DEVIATIONS WERE FOUND. BASED ON ASSESSMENT OF PRODUCTION LOGS AND DHR, TRUE ROOT CAUSE CANNOT BE ARRIVED AT. HENCE, IT CANNOT BE DETERMINED IF THE PRODUCT IS NON-CONFORMING. UPON FURTHER, IT WAS DETERMINED THAT THE INITIAL COMPLAINT WAS SUBMITTED IN ERROR. BASED UPON CLINICAL INPUT FROM POST MARKET CLINICAL ADMINISTRATOR AND CONSULTING CLINICIAN: THERE WAS NO REPORTED DELAY IN THE PROCEDURE, THIS MALFUNCTION IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF IT WERE TO RECUR AND THIS COMPLAINT DOES NOT MEET THE CRITERIA OF REPORTABLE COMPLAINT.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT HE ORDERED AN EXTERNAL HEX HEALING ABUTMENT, UPON RECEIPT AND INSPECTION THE DOCTOR REALIZED THAT THE LABEL INDICATED EXTERNAL HEX HEALING ABUTMENT BUT INSIDE THE PACKAGE WAS AN INTERNAL HEX HEALING ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427569 EP® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) EP® HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) NHA BIOMET 3I N/A 1166681

    Patients

    Seq Age Sex Outcome Treatment
    1