BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMENT G

    MDR report key: 23484304 · Received November 6, 2025

    Report

    Report Number
    3005304945-2025-00005
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    November 8, 2024
    Report Date
    November 4, 2025
    Manufacturer
    BONEUSUPPORT AB
    Product Code
    QRR
    PMA / PMN Number
    K234008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INSTRUCTIONS FOR USE, IFU0028-05, IT IS STATED THAT "CERAMENT G ATTAINS FINAL SETTING AT 20 MINUTES.". REVIEW OF BATCH RECORDS INCLUDING QUALITY CONTROL RELEASE RESULTS SHOWED THAT THE RESULTS FROM RELEASE TESTING WERE WITHIN LIMITS. 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. DESCRIPTION OF PREPARATION OF CERAMENT G PASTE AVAILABLE IN IFU-0028-05. THE LOT WAS RELEASED 2024-01-03. ACCORDING TO INFORMATION FROM CUSTOMER SERVICE, THE LOT HAS BEEN SOLD OUT (0 PRODUCTS LEFT OUT OF A BATCH SIZE OF 756). THERE HAVE NOT BEEN ANY OTHER COMPLAINTS REGARDING SLOW SETTING FOR THE AFFECTED PRODUCT LOT. IT WAS CONFIRMED BY THE SALES REPRESENTATIVE THAT THE PRODUCT WAS MIXED CORRECTLY. THE EXACT ROOT CAUSE OF THE EVENT IS DIFFICULT TO STATE AS THE PRODUCT WAS NOT AVAILABLE FOR VISUAL INSPECTION. NO SERIOUS OUTCOMES WERE REPORTED. 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 WAS TOO LIMITED TO RULE OUT: - THAT IT COULD CONTRIBUTE TO SERIOUS INJURY IF MALFUNCTION WERE TO RECUR (21 CFR PART 803). IT WAS THEREFORE, DECIDED TO REPORT THE INCIDENT TO US FDA, WITHIN A DEADLINE OF 30 DAYS (COUNTING FROM 28TH OF OCTOBER 2025).

    Description of Event or Problem · 0

    INITIALLY IT WAS REPORTED THAT: CERAMENT G KIT WAS MIXED CORRECTLY BUT THE PRODUCT WAS DELAYED SETTING UP, WAS STILL VERY RUNNY AT 12 MINUTES AND WOULD NOT STAY IN THE DEFECTS. TOURNIQUET WAS USED. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 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 US FDA. 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
    2677526 CERAMENT G CERAMENT G QRR BONEUSUPPORT AB A0535-06 MLOT1195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other