BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A&E MEDICAL / THORECON¿ BOX CABLE PLATE KIT

    MDR report key: 16598330 · Received March 23, 2023

    Report

    Report Number
    0002242056-2023-00003
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    February 22, 2023
    Report Date
    June 30, 2023
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    JEY
    UDI-DI
    10841291107224
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION B4, B5, D6, G3, G6, H2, H6 AND H10.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). PRODUCT CODE: IKD. PRODUCT NAME: CABLE, ELECTRODE. CONCOMITANT MEDICAL PRODUCTS: ITEM # 94-1400-04, LOT 429742; A&E MEDICAL / THORECON¿ BOX CABLE PLATE KIT (INC. SCREWS & CABLE); ITEM # 94-1500-04-S, LOT 424623; A&E MEDICAL / THORECON¿ AUXILIARY CABLE PLATE KIT (INC. SCREWS & CABLE); ITEM # UNK, LOT # UNK; UNKNOWN 14 MM SCREW. 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: 0002242056-2023-00004, 0002242056-2023-00005, 0002242056-2023-00006.

    Description of Event or Problem · 0

    IT IS FURTHER REPORTED THROUGH MEDICAL RECORDS THAT THE PATIENT HAD AN INITIAL CORONARY ARTERY BYPASS GRAFT PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SUPERFICIAL AND DEEP WOUND DEBRIDEMENT WITH REMOVAL OF STERNAL PLATING SYSTEM AND VAC PLACEMENT SURGERY DUE TO WOUND DEHISCENCE, SURGEON REPORTED POSSIBLE METAL ALLERGY REACTION WITHIN THE TISSUE, APPROXIMATELY THREE (3) MONTHS POST-IMPLANTATION. DURING THE PROCEDURE THE BONE WAS FOUND TO BE HEALTHY AND STABLE. THERE WAS INFLAMMATORY TISSUE NOTED AROUND EACH STERNAL PLATE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

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

    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 IS REPORTED THE PATIENT WAS REVISED OF A STERNAL CONSTRUCT DUE TO ABNORMAL TISSUE RESPONSES OVER THE PLATE SITES. THE SURGEON INDICATED THE POSSIBILITY OF A METAL ALLERGY REACTION WITHIN THE TISSUE. AT THE TIME OF THE REVISION, THE STERNAL HEALING HAD BEEN ACHIEVED WELL. 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
    480830 A&E MEDICAL / THORECON¿ BOX CABLE PLATE KIT PLATE, BONE JEY A&E MEDICAL CORPORATION N/A 429742 10841291107224

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H