BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    BIOHORIZONS ABUTMENT

    MDR report key: 12786519 · Received November 10, 2021

    Report

    Report Number
    1060818-2021-12030
    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

    THERE ARE A TOTAL OF 9 MALFUNCTIONED EVENTS WITH A STRIPPED ABUTMENT. 8 OF THE 9 UNITS DID NOT HAVE PRODUCT RETURNED FOR EVALUATION. SINCE, PRODUCT WAS NOT RETURNED FOR EVALUATION NO CONCLUSION MAY BE DRAWN TO THE CAUSE OF THE STRIPPED ABUTMENTS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NOTED NONCONFORMANCES. HENCE, THE DEVICES WERE MANUFACTURED TO SPECIFICATIONS. 1 OF THE 9 UNITS WERE RETURNED FOR EVALUATION. IT WAS CONCLUDED THE EVALUATION WAS DAMAGED BY THE END USER. THE FAILURE CAUSE WAS IMPROPER TECHNIQUE BY THE END USER. UPDATED INFORMATION THE ORIGINAL FILE WAS SENT ON 10/29/2021 FOR 3RD QUARTER. ADDITIONALLY, THE DETAILS FOR REPORT NUMBER 1060818-2021-12030 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 1060818-2021-12030 BECAUSE 1060818-2021-12030 HAD ALREADY BEEN USED AND TRANSMITTED. REPORT NUMBER 1060818-2021-12030 WAS ORIGINALLY SLATED FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT COVERING FRACTURED HEX ABUTMENTS. MFR REPORT NUMBER 1060818-2021-15684 WAS CREATED TO ALLOW FOR THE CORRECTION OF THE SINGLE MDR EVENT ASSOCIATED WITH COMPLAINT NUMBER (B)(4). OVERALL, THE SUBMISSION OF 1060818-2021-12030 IS TO CORRECT AND REINSTATE REPORT 1060818-2021-12030 WHICH WAS OVERWRITTEN IN ERROR ON 11/10/2021.

    Additional Manufacturer Narrative · 0

    THERE ARE A TOTAL OF 9 MALFUNCTIONED EVENTS WITH A STRIPPED ABUTMENT. 8 OF THE 9 UNITS DID NOT HAVE PRODUCT RETURNED FOR EVALUATION. SINCE, PRODUCT WAS NOT RETURNED FOR EVALUATION NO CONCLUSION MAY BE DRAWN TO THE CAUSE OF THE STRIPPED ABUTMENTS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NOTED NONCONFORMANCES. HENCE, THE DEVICES WERE MANUFACTURED TO SPECIFICATIONS. 1 OF THE 9 UNITS WERE RETURNED FOR EVALUATION. IT WAS CONCLUDED THE EVALUATION WAS DAMAGED BY THE END USER. THE FAILURE CAUSE WAS IMPROPER TECHNIQUE BY THE END USER. UPDATED INFORMATION THE ORIGINAL FILE WAS SENT ON 10/29/2021 FOR 3RD QUARTER. ADDITIONALLY, THE DETAILS FOR REPORT NUMBER 1060818-2021-12030 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 1060818-2021-12030 BECAUSE 1060818-2021-12030 HAD ALREADY BEEN USED AND TRANSMITTED. REPORT NUMBER 1060818-2021-12030 WAS ORIGINALLY SLATED FOR THE 2021 3RD QUARTER VOLUNTARY SUMMARY MALFUNCTION REPORT COVERING FRACTURED HEX ABUTMENTS. MFR REPORT NUMBER 1060818-2021-15684 WAS CREATED TO ALLOW FOR THE CORRECTION OF THE SINGLE MDR EVENT ASSOCIATED WITH COMPLAINT NUMBER (B)(4). OVERALL, THE SUBMISSION OF 1060818-2021-12030 IS TO CORRECT AND REINSTATE REPORT 1060818-2021-12030 WHICH WAS OVERWRITTEN IN ERROR ON 11/10/2021.

    Additional Manufacturer Narrative · 0

    THERE WAS A TOTAL OF 9 MALFUNCTIONED EVENTS ASSOCIATED WITH A STRIPPED ABUTMENT. 8 OF THE 9 UNITS WERE NOT RETURNED FOR INVESTIGATION. SINCE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NOTED NONCONFORMANCE. HENCE, THE CONCLUSIONS DETERMINED THE UNITS WERE MANUFACTURED TO SPECIFICATIONS. 1 OF THE 9 UNITS WERE RETURNED DAMAGED BY THE END USER. FAILURE CAUSED BY IMPROPER TECHNIQUE OR IMPROPER USE OF PRODUCT. ITEMS INVOLVED - ABUTMENT SCREW, MULTI-UNIT ABUTMENT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED ABUTMENTS THAT HAVE STRIPPED. THE REPORT WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED ABUTMENTS THAT HAVE STRIPPED. THE REPORT WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INVOLVED STRIPPED ABUTMENT. THE REPORT WAS RECEIVED FROM VARIOUS SOURCES. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING THE PATIENT DEMOGRAPHICS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682817 BIOHORIZONS ABUTMENT CUSTOM CAST - MULTI-UNIT ABUTMENT NHA BIOHORIZONS IMPLANT SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown