BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTHETIC ABUTMENT CC RP 1.5MM

    MDR report key: 8921442 · Received August 22, 2019

    Report

    Report Number
    2027971-2019-00745
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    NHA
    UDI-DI
    07332747032598
    PMA / PMN Number
    K071370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER: (B)(4). MANUFACTURER NARRATIVE: INVESTIGATION SUMMARY: NO COMPLAINT FILE OR PRODUCT WERE RETURNED. THEREFORE A VISUAL INSPECTION AND FUNCTION TEST COULD NOT BE PERFORMED. THE CUSTOMER DECIDED NOT TO RETURN THE PRODUCT. THE CUSTOMER DECIDED TO USE THE ABUTMENT WITH A DIFFERENT SCREW. TREND ANALYSIS INDICATED THAT THERE WAS 1 SIMILAR COMPLAINT DESCRIPTION FOR THIS MATERIAL AND BATCH COMBINATION. THE MANUFACTURING SITE WAS CONTACTED FOR A DEVICE HISTORY REVIEW (DHR) ON (B)(6) 2019. DHR REVIEW SHOWED NO DEVIATIONS AND THE RETAIN SAMPLE CONFORMED. THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE PRODUCT BEING RETURNED UNOPENED AND IN THE ORIGINAL NOBEL BIOCARE PACKAGING. ALL STOCK WAS INSPECTED AND THERE DID NOT APPEAR TO BE A SYSTEMIC ISSUE. RISK ANALYSIS CONCLUDED THAT THE SCREW WILL NOT FEEL TIGHT WHEN PLACED DUE TO THE NARROW PLATFORM, SO THE CUSTOMER WILL NOT ACCIDENTALLY PLACE THE WRONG SCREW. THE NEED FOR A POSSIBLE FIELD ACTION (PFA) WAS EVALUATED AND IT WAS CONCLUDED THAT NO PFA IS NECESSARY. RESULTS OF THE INVESTIGATION DO NOT INDICATE A SYSTEMIC ISSUE WITHIN THE BATCH. THE NEED FOR A PFA WILL BE RE-EVALUATED IN CASE ADDITIONAL COMPLAINTS ARE RECEIVED FOR THIS BATCH. CORRECTED DATA: ADDITIONAL INFORMATION NOT INCLUDED IN THE PRIOR SUBMISSION ARE AS FOLLOWS: THE DATE OF EVENT, PATIENT IDENTIFIER: "NONE" ,THE DEVICE WAS NOT EVALUATED BY THE MANUFACTURE BECAUSE THE CUSTOMER DID NOT RETURN THE PRODUCT AND METHOD CODES 4109 AND 4114 HAVE BEEN ADDED.

    Description of Event or Problem · 1

    NOBEL BIOCARE WAS VERBALLY INFORMED BY THE CUSTOMER ON THE (B)(6) 2019 THAT ORDERED MATERIAL #36669 (ESTHETIC ABUTMENT CC RP 1.5MM) BATCH #13075989 CONTAINED AN INCORRECT SCREW. THE CUSTOMER DID NOT RETURN THE ABUTMENT AN WILL USE A NEW SCREW INSTEAD OF THE INCORRECT SCREW THEY RECEIVED IN THE PACKAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS MOMENT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT THAT THE INCORRECT SCREW WAS ENCLOSED WITH ABUTMENT, PRODUCT NUMBER 36669. THE SCREW WAS A NARROW PLATFORM RATHER THAN THE NEEDED REGULAR PLATFORM. THE CUSTOMER STATES THAT THE PRODUCT WAS NOT USED ON A PATIENT. HE DECLINED TO SEND THE PRODUCT BACK AND STATED THAT THE ABUTMENT WILL BE USED. HE JUST NEEDED A NEW SCREW SENT TO HIM AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714257 ESTHETIC ABUTMENT CC RP 1.5MM ENDOSSEOUS DENTAL IMPLANT ABUTMENT. NHA NOBEL BIOCARE USA, LLC 36669 13075989 07332747032598

    Patients

    Seq Age Sex Outcome Treatment
    1