BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN RIBFIX BLU PLATE

    MDR report key: 19361244 · Received May 21, 2024

    Report

    Report Number
    0001032347-2024-00164
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    September 18, 2023
    Report Date
    May 31, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K142823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). G2: LITERATURE: JOURNAL ARTICLE O¿CONNOR, L. A. (N.D.). INTERCOSTAL CRYONERVE BLOCK VERSUS ELASTOMERIC INFUSION PUMP FOR POSTOPERATIVE ANALGESIA FOLLOWING SURGICAL STABILIZATION OF TRAUMATIC RIB FRACTURES [REVIEW OF INTERCOSTAL CRYONERVE BLOCK VERSUS ELASTOMERIC INFUSION PUMP FOR POSTOPERATIVE ANALGESIA FOLLOWING SURGICAL STABILIZATION OF TRAUMATIC RIB FRACTURES]. INJURY, 54. ELSEVIER. HTTPS://DOI.ORG/10.1016/J.INJURY.2023.111053 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM ELSEVIER (2023) THAT REPORTED A RETROSPECTIVE, COMPARATIVE STUDY FROM UNITED STATES. THE PURPOSE OF THE STUDY WAS TO COMPARE CRYO-NERVE BLOCK (CRYONB) OR ELASTOMERIC INFUSION PUMP (EIP). THE STUDY REVIEWED 26 SURGICAL STABILIZATION OF RIB FRACTURES (SSFR). THE INDICATION FOR SSFR WAS TRAUMATIC RIB FRACTURES AND WAS COMPLETED USING THE MUSCLE-SPARING TECHNIQUE, FRACTURE PREPARATION FOR OSTEOSYNTHESIS, DIRECT REDUCTION, AND THORACIC FIXATION SYSTEM PLATES AND SCREWS USING ZIMMER BIOMET RIBFIX BLU, AND CHEST TUBE PLACEMENT WITH 12 PATIENTS RECEIVING THE EIB AND 14 PATIENTS RECEIVED THE CYRONB FOR PAIN CONTROL. THE EIB WAS PLACED AT THE END OF THE SURGERY WHILE THE CRYONB WAS PERFORMED AT THE BEGINNING OF THE PROCEDURE. THE STUDY POPULATION HAD A MEAN AGE OF CRYONB 54, EIB 52 YEARS AT TIME OF SURGERY; 18 MALES AND 8 FEMALES. FOLLOW-UP WAS CONDUCTED AT WITH A MEAN LENGTH FOR 36 MONTHS, FROM OCTOBER 5, 2017 TO NOVEMBER 10, 2020. THE STUDY REPORTED 2 PATIENTS WITH THE EIP REPORTED PERSISTENT CHEST WALL PAIN AT 1 YEAR FOLLOW UP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583884 UNKNOWN RIBFIX BLU PLATE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other