BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBFIX BLU SYSTEM 12 HOLE PRE-BENT PLATE

    MDR report key: 11121473 · Received January 5, 2021

    Report

    Report Number
    0001032347-2021-00009
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    September 23, 2020
    Report Date
    September 30, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036184315
    PMA / PMN Number
    K142823
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM. HOWEVER, AS THE LOT NUMBER IS UNKNOWN, AN ADDITIONAL REVIEW COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS CONFIRMED REVISION FOR FRACTURE. THE IMPLANTS WERE SENT TO PATHOLOGY AND WERE NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00010. CONCOMITANT MEDICAL PRODUCTS RIBFIX BLU SYSTEM 12 HOLE PRE-BENT PLATE, PART# 76-2602, LOT# NI, ZIMMER BIOMET. RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10MM, PART# 76-2410, LOT# NI, ZIMMER BIOMET. DYNAGRAFT II, PART# 02-2000-050, LOT# 161227, ISOTIS ORTHOBIOLOGICS. INITIAL REPORTER OCCUPATION ¿ PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION TO REMOVE A RIB PLATE TWO YEARS FOLLOWING IMPLANTATION DUE TO PLATE FRACTURE AND PAIN. TWO YEARS AGO, THE PATIENT WAS IMPLANTED WITH A RIB PLATE DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A RIB FRACTURE WITH NON-UNION ON THE LEFT 11TH RIB. THE PATIENT EXPERIENCED CONSTANT PAIN FOLLOWING IMPLANTATION. THE SURGEON DISCOVERED THE PLATE WAS FRACTURED AND REMOVED THE PLATE AND RIB BONE. THE PATIENT NOW DESCRIBES HIS CONDITION AS GREAT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17884 RIBFIX BLU SYSTEM 12 HOLE PRE-BENT PLATE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A UNK 00841036184315

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R