BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNK STERNALOCK PLATE

    MDR report key: 22012570 · Received May 13, 2025

    Report

    Report Number
    0001032347-2025-00204
    Event Type
    Injury
    Date Received
    May 13, 2025
    Report Date
    March 27, 2026
    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 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. 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. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE REPORTED EVENT IS UNCONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION 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 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. THREE PATIENTS WERE READMITTED WITHIN 30 DAYS FOR AN UNKNOWN STERNAL WOUND CONCERN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369152 UNK STERNALOCK PLATE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H