BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    BIOHORIZONS ABUTMENT

    MDR report key: 12786515 · Received November 10, 2021

    Report

    Report Number
    1060818-2021-12028
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOOSE ABUTMENT WAS CAUSED BY THE PATIENT NOT FOLLOWING AFTER-CARE INSTRUCTIONS. THE PATIENT BIT INTO SOMETHING HARD WHICH CONTRIBUTED TO THE MOVEMENT CASUE THE ABUTMENT TO BECOME LOOSE. THE DAMAGED ABUTMENT WAS RETURNED FOR EVALUATION. NONCONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THE ITEM. THEREFORE, THE ITEM WAS MANUFACTURED TO SPECIFIATIONS. NOT FOLLOWING AFTER-CARE INSTRUCTIONS CAN CONTRIBUTED TO THE ABUTMENT MALFUNCTIONING. UPDATED INFORMATION THE ORIGINAL FILE WAS SENT ON 10/29/2021 FOR 3RD QUARTER 2021.THE DETAILS FOR REPORT NUMBER 1060818-2021-12028 WERE PREVIOUSLY SUBMITTED ON 10/29/2021. THE ORIGINAL REPORT WAS ACCIDENTALLY OVERWRITTEN ON 11/10/2021 WHEN A SINGLE MDR EVENT DATED 10/11/2021 FOR COMPLAINT (B)(4) WAS PROCESSED, KEYED, AND TRANSMITTED. THE SINGLE MDR EVENT FOR COMPLAINT (B)(4) SHOULD HAVE NOT BEEN ASSIGNED 1060818-2021-12028 BECAUSE 1060818-2021-12028 HAD ALREADY BEEN USED AND TRANSMITTED. REPORT NUMBER 1060818-2021-12028 WAS ORIGINALLY SLATED FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT COVERING FRACTURED HEX ABUTMENTS. MFR REPORT NUMBER 1060818-2021-15682 WAS CREATED TO ALLOW FOR THE CORRECTION OF THE SINGLE MDR EVENT ASSOCIATED WITH COMPLAINT NUMBER (B)(4). OVERALL, THE SUBMISSION OF 1060818-2021-12028 IS TO CORRECT AND REINSTATE REPORT 1060818-2021-12028 WHICH WAS OVERWRITTEN IN ERROR ON 11/10/2021.

    Additional Manufacturer Narrative · 0

    THE LOOSE ABUTMENT WAS CAUSED BY THE PATIENT NOT FOLLOWING AFTER-CARE INSTRUCTIONS. THE PATIENT BIT INTO SOMETHING HARD WHICH CONTRIBUTED TO THE MOVEMENT CAUSE THE ABUTMENT TO BECOME LOOSE. THE DAMAGED ABUTMENT WAS RETURNED FOR EVALUATION. NONCONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THE ITEM. THEREFORE, THE ITEM WAS MANUFACTURED TO SPECIFICATIONS. NOT FOLLOWING AFTER-CARE INSTRUCTIONS CAN CONTRIBUTED TO THE ABUTMENT MALFUNCTIONING. UPDATED INFORMATION THE ORIGINAL FILE WAS SENT ON 10/29/2021 FOR 3RD QUARTER 2021. THE DETAILS FOR REPORT NUMBER 1060818-2021-12028 WERE PREVIOUSLY SUBMITTED ON 10/29/2021. THE ORIGINAL REPORT WAS ACCIDENTALLY OVERWRITTEN ON 11/10/2021 WHEN A SINGLE MDR EVENT DATED 10/11/2021 FOR COMPLAINT (B)(4) WAS PROCESSED, KEYED, AND TRANSMITTED. THE SINGLE MDR EVENT FOR COMPLAINT (B)(4) SHOULD HAVE NOT BEEN ASSIGNED 1060818-2021-12028 BECAUSE 1060818-2021-12028 HAD ALREADY BEEN USED AND TRANSMITTED. REPORT NUMBER 1060818-2021-12028 WAS ORIGINALLY SLATED FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT COVERING FRACTURED HEX ABUTMENTS. MFR REPORT NUMBER 1060818-2021-15682 WAS CREATED TO ALLOW FOR THE CORRECTION OF THE SINGLE MDR EVENT ASSOCIATED WITH COMPLAINT NUMBER (B)(4). OVERALL, THE SUBMISSION OF 1060818-2021-12028 IS TO CORRECT AND REINSTATE REPORT 1060818-2021-12028 WHICH WAS OVERWRITTEN IN ERROR ON 11/10/2021.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED LOOSE ABUTMENT. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED LOOSE ABUTMENT. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT THE REPORTED ABUTMENT DEMONSTRATED A LOOSE ABUTMENT. THE REPORT WAS RECEIVED FROM ONE SOURCE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING THE PATIENT DEMOGRAPHIC WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682804 BIOHORIZONS ABUTMENT CUSTOM CAST - MULTI-UNIT ABUTMENT NHA BIOHORIZONS IMPLANT SYSTEMS PYHYB 1906839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown