BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENDER 11" TI PECTUS BAR

    MDR report key: 8235514 · Received January 10, 2019

    Report

    Report Number
    0001032347-2019-00029
    Event Type
    Injury
    Date Received
    January 10, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K061384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF EVIDENCE TO SUGGEST THE REVISION WAS TO TAKE PLACE. IT WAS REPORTED THAT THIS 11" PECTUS BAR WAS IMPLANTED ON (B)(6), 2018. THE REVISION SURGERY WAS SCHEDULED TO TAKE PLACE ON JAN 16, 2019, AND THE 11" PECTUS BAR WAS GOING TO BE REPLACED WITH AN 11.5" PECTUS BAR. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). EVENT DATE: ANTICIPATED DATE OF REVISION IS (B)(6) 2019. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). EXPLANTED DATE: ANTICIPATED DATE OF REVISION IS (B)(6) 2019. MEDICAL DEVICE: BIOMET MICROFIXATION PECTUS SYSTEM ELONGATED STABILIZER 60 X 17 MM TITANIUM, CATALOG #: 01-3802, LOT #: NI. THERAPY DATE: ANTICIPATED DATE OF REVISION IS (B)(6) 2019. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION; SINCE THE REVISION HAS NOT BEEN CONFIRMED, THE PRODUCT MAY STILL BE IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00030.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION OF A PECTUS BAR WILL OCCUR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28707 BENDER 11" TI PECTUS BAR PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 806650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R