BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMENT G

    MDR report key: 23473680 · Received November 5, 2025

    Report

    Report Number
    3005304945-2025-00004
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    May 15, 2025
    Report Date
    November 4, 2025
    Manufacturer
    BONEUSUPPORT AB
    Product Code
    QRR
    PMA / PMN Number
    K234008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS DISCARDED. REVIEW OF BATCH RECORDS INCLUDING QUALITY CONTROL RELEASE RESULTS SHOWED THAT THE RESULTS FROM RELEASE TESTING WERE WITHIN LIMITS. MLOT1370 WAS RELEASED 2024-09-04, A TOTAL AMOUNT OF (B)(4) AND THERE ARE 14 LEFT IN STOCK. THERE HAVE NOT BEEN ANY SIMILAR COMPLAINTS ON THE AFFECTED BATCH. IT SHOULD BE NOTED THAT A LONGER SETTING TIME WILL NOT AFFECT THE FINAL IMPLANTED MATERIAL I.E. THE MATERIAL WILL HAVE THE SAME POROSITY AND THE ELUTION OF GENTAMICIN WILL BE THE SAME. IT WAS CONFIRMED BY THE SALES REPRESENTATIVE THAT THE CORRECT AMOUNT/PROCEDURE WAS USED/DONE. EVEN THOUGH THE RELEASE TESTING WERE WITHIN LIMITS, THE SETTING TIMES FOR THIS BATCH WERE CLOSER TO THE UPPER RANGE, THIS MEANS THAT THE USER CAN EXPERIENCE THE SETTING TIME AS SLOWER THAN USUAL, DUE TO NORMAL BATCH TO BATCH VARIATION. THE EXACT ROOT CAUSE IS DIFFICULT TO STATE AS THE PRODUCT WAS NOT AVAILABLE FOR VISUAL INSPECTION. BUT A LIKELY EXPLANATION IS THE NORMAL BATCH TO BATCH VARIATION, MEANING THAT THE BATCH COULD BE EXPERIENCE AS SLOWER EVEN THOUGH BEEING WITHIN LIMITS. TO CONCLUDE THE INFORMATION TO THIS INCIDENT WAS CONCLUDED TO BE TOO LIMITED TO RULE OUT (TAKEN INTO ACCOUNT ABOVE RISKS): 1. MIGHT HAVE LED OR MIGHT LEAD TO ANY OF THE OUTCOMES OF A SERIOUS INCIDENT (MDR/POST-MARKET SURVEILLANCE REQUIREMENTS, AMENDMENT, GREAT BRITAIN, REGULATIONS 2024). 2. THAT IT COULD CONTRIBUTE TO SERIOUS INJURY IF MALFUNCTION WERE TO RECUR (21 CFR PART 803). 3. THAT THE INCIDENT COULD LEAD TO SERIOUS DETERIORATION IN THE STATE OF HEALTH IF IT WOULD RECUR (SOR/98-282 HEALTH CANADA AND THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002) TO CONCLUDE THIS INCIDENT DID NOT LEAD TO ANY SERIOUS INCIDENT (INCLUDING SERIOUS DETERIORATION IN THE STATE OF HEALTH), SERIOUS INJURY OR DEATH. HOWEVER, SINCE THE INFORMATION IS TOO LIMITED TO RULE OUT THE ABOVE-MENTIONED FACTORS, IT WAS DECIDED TO REPORT THE INCIDENT TO COMPETENT AUTHORITY IN NETHERLANDS (THE HEALTH AND YOUTH CARE INSPECTORATE (IGJ), NOTIFIED BODY (BSI) AND FDA (US).

    Description of Event or Problem · 0

    INITIAL RECEIVED INFORMATION - 16TH MAY 2025: OUR ISSUE OCCURRED DURING A SURGERY ON A FEMALE PATIENT THAT NEEDED TREATMENT OF THE CALCANEUS. THE GOAL WAS TO PERFORM A SILO TECHNIQUE, FILLING UP 5 POCKET HOLES. MIXING TECHNIQUES WAS DONE ACCORDING TO IFU AND THE PRODUCT WAS HANDED OFF TO THE SURGEON AT THE 4 MIN MARK. FIRST COMPLAINT WAS THAT THE DOCTOR HAD A FEELING THAT THE PRODUCT WAS TOO LIQUID AND DIDN'T STAY IN PLACE. THE SETTING OF THE PRODUCT APPEARED TO BE OFF AND IT LOOKED BECAUSE IT DIDN'T HARDEN WITH IN THE TIME FRAME OF 15 MIN. THE REST OF THE PRODUCT IN THE TRAY BECAME DRY, POWDERY, AND CRUMBLY AFTER AROUND 18-19 MIN. THIS INCIDENT WAS INITALLY DETERMINED NOT TO BE REPORTABLE. HOWEVER, DUE TO AN INTERNAL CAPA IT WAS DECIDED TO PERFORM A PERIODIC REVIEW OF INCIDENTS OVER THE LAST 12-MONTHS (COUNTING FROM 1ST OCTOBER 2025 AND BACKWARDS). THE INFORMATION TO THIS INCIDENT WAS CONCLUDED TO BE TOO LIMITED TO RULE OUT (TAKEN INTO ACCOUNT THE CONNECTED RISKS): 1. MIGHT HAVE LED OR MIGHT LEAD TO ANY OF THE OUTCOMES OF A SERIOUS INCIDENT (MDR/POST-MARKET SURVEILLANCE REQUIREMENTS, AMENDMENT, GREAT BRITAIN, REGULATIONS 2024). 2. THAT IT COULD CONTRIBUTE TO SERIOUS INJURY IF MALFUNCTION WERE TO RECUR (21 CFR PART 803). 3. THAT THE INCIDENT COULD LEAD TO SERIOUS DETERIORATION IN THE STATE OF HEALTH IF IT WOULD RECUR (SOR/98-282 HEALTH CANADA AND THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002) TO CONCLUDE THIS INCIDENT DID NOT LEAD TO ANY SERIOUS INCIDENT (INCLUDING SERIOUS DETERIORATION IN THE STATE OF HEALTH), SERIOUS INJURY OR DEATH. HOWEVER, SINCE THE INFORMATION IS TOO LIMITED TO RULE OUT THE ABOVE-MENTIONED FACTORS, IT HAS BEEN DECIDED TO REPORT THE INCIDENT TO COMPETENT AUTHORITY IN NETHERLANDS (THE HEALTH AND YOUTH CARE INSPECTORATE (IGJ), NOTIFIED BODY (BSI) AND FDA (US). MANUFACTURER AWARENESS DATE OF REPORTABILITY: 28TH OCTOBER 2025 REPORTING DEADLINE FDA: WITHIN 30-DAYS FROM MANUFACTURER AWARENESS DATE OF REPORTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2693549 CERAMENT G CERAMENT G QRR BONEUSUPPORT AB A0535-01 MLOT1370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other