BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMENT G

    MDR report key: 24331659 · Received February 13, 2026

    Report

    Report Number
    3005304945-2026-00001
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 27, 2026
    Report Date
    March 16, 2026
    Manufacturer
    BONEUSUPPORT AB
    Product Code
    QRR
    UDI-DI
    07350055430523
    PMA / PMN Number
    K234008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIMITED INFORMATION WAS REPORTED: SINUS AND DEHISCENCE 6 WEEKS POST-OP OF INITIAL PLACEMENT OF 10 ML'S OF CG. DOCTOR WAS TAKING PATIENT BACK TO OR FOR I.D. BATCH NUMBER IS NOT KNOWN, THEREFORE IT IS NOT POSSIBLE TO PERFORM ANY BATCH REVIEW. BUT GENERAL TRENDS AND COMPLAINT DATA DOES NOT INDICATE ANY BATCH-SPECIFIC ISSUE. THE INFORMATION PROVIDED RELATED TO THE INCIDENT WAS TOO LIMITED. QUESTIONS LIKE PATIENT CHARACTERISTICS, AGE, TYPE OF SURGERY, TESTS/LABORATORY DATA, RADIOGRAPHS ETC. CANNOT BE ANSWERED. DUE TO THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO CONDUCT A MEDICAL INVESTIGATION AT THIS TIME. SINUS FORMATION AND WOUND DEHISCENCE MAY BE CONSIDERED POTENTIAL COMPLICATIONS OF ANY SURGICAL PROCEDURE. RISK ASSESSMENT AND PRECAUTIONS / POTENTIAL ADVERSE EVENTS / DIRECTIONS FOR USE IN INSTRUCTIONS FOR USE ALREADY COVER THE OCCURRED EVENT, AND HENCE IT CAN BE CONCLUDED THAT THERE ARE NO CORRECTIVE ACTIONS REQUIRED.

    Additional Manufacturer Narrative · 0

    LIMITED INFORMATION WAS REPORTED: SINUS AND DEHISCENCE 6 WEEKS POST-OP OF INITIAL PLACEMENT OF 10 ML'S OF CG. DOCTOR WAS TAKING PATIENT BACK TO OR FOR I.D. BATCH NUMBER IS NOT KNOWN; THEREFORE, IT IS NOT POSSIBLE TO PERFORM ANY BATCH REVIEW. BUT GENERAL TRENDS AND COMPLAINT DATA DOES NOT INDICATE ANY BATCH-SPECIFIC ISSUE. MORE INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

    LIMITED INFORMATION WAS REPORTED: SINUS AND DEHISCENCE 6 WEEKS POST-OP OF INITIAL PLACEMENT OF 10 ML'S OF CG. DOCTOR WAS TAKING PATIENT BACK TO OR FOR I.D. BATCH NUMBER IS NOT KNOWN, THEREFORE IT IS NOT POSSIBLE TO PERFORM ANY BATCH REVIEW. BUT GENERAL TRENDS AND COMPLAINT DATA DOES NOT INDICATE ANY BATCH-SPECIFIC ISSUE. NO FURTHER INFORMATION WAS RECEIVED REGARDING THE BATCH.

    Description of Event or Problem · 0

    LIMITED INFORMATION WAS REPORTED: SINUS AND DEHISCENCE 6 WEEKS POST-OP OF INITIAL PLACEMENT OF 10 ML'S OF CG. DOCTOR WAS TAKING PATIENT BACK TO OR FOR I.D. BATCH NUMBER IS NOT KNOWN, THEREFORE IT IS NOT POSSIBLE TO PERFORM ANY BATCH REVIEW. BUT GENERAL TRENDS AND COMPLAINT DATA DOES NOT INDICATE ANY BATCH-SPECIFIC ISSUE. MORE INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113238 CERAMENT G CERAMENT G QRR BONEUSUPPORT AB A0535-05 07350055430523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H