BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK STERNALOCK PLATE

    MDR report key: 22012604 · Received May 13, 2025

    Report

    Report Number
    0001032347-2025-00206
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    July 17, 2024
    Report Date
    July 24, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 (COMPONENT CODE) THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. PRODUCT HAS NOT BEEN RETURNED. NO PRODUCT EVALUATION WAS ABLE TO BE COMPLETED. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. IT WAS REPORTED THAT 1 PATIENT IN THE STUDY REQUIRED REOPERATION DUE TO BLEEDING. PATIENTS IN THE STUDY WERE UNDERGOING HIGH RISK CARDIAC SURGERIES AND CLOSED WITH STERNAL FIXATION DEVICES. THESE DEVICES ARE USED AS ADJUNCT THERAPY AND PLACED AT THE END OF THE PROCEDURE TO SUPPORT PROPER BONE FIXATION AND HEALING. THE AUTHOR CONFIRMED THAT NO DEVICE RELATED COMPLICATIONS OCCURRED. THEREFORE, PATIENT OUTCOMES ARE ATTRIBUTED TO THE CARDIAC PROCEDURE OR UNDERLYING PATIENT CARDIAC COMORBIDITIES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (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. GERDISCH, MARC, JOHNS, CHANICE M, BARKSDALE, ANDREW, PARIKSHAK, MANESH. RIGID STERNAL FIXATION AND ENHANCED RECOVERY FOR OPIOID-FREE ANALGESIA AFTER CARDIAC SURGERY. ANN THORAC SURG. 2024;118(4):931-939. HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2024.06.032.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE FROM PERIOPERATIVE & CRITICAL CARE: RESEARCH, WHICH STUDIED CONTRIBUTIONS OF RIGID PLATE FIXATION ON POSTOPERATIVE PAIN, OPIOID USE, AND OTHER STERNOTOMY OUTCOMES. ONE PATIENT UNDERWENT REOPERATION FOR BLEEDING WITHIN AN UNKNOWN TIMEFRAME FROM AN UNKNOWN SOURCE. IT IS NOT KNOWN WHETHER THIS WAS A DEVICE RELATED COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967451 UNK STERNALOCK PLATE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R