BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMENT G

    MDR report key: 23765401 · Received December 10, 2025

    Report

    Report Number
    3005304945-2025-00006
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BONEUSUPPORT AB
    Product Code
    QRR
    PMA / PMN Number
    K234008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE USED THE INFORMATION FROM THE OBSERVATION FORMS, THE COMMUNICATION, EVALUATED THE AVAILABLE IMAGE AND RESULTS OF THE LABORATORY INVESTIGATION OF PARTICLES. AS WE KNOW FROM THE OBSERVATION FORM GENTAMICIN SOLUTION WAS PREPARED AS PER IFU AND SMALL PARTICLE WAS NOTICED IN THE VIAL. THE NURSE CONTINUED MIXING USING THE SOLUTION WITHOUT THE PARTICLE. APPROXIMATELY 3 ML OF CERAMENT G (PRODUCT 1/A) PASTE WAS IMPLANTED INTO THE LEFT RADIUS AFTER DEBRIDEMENT. THE PARTICLE WAS LEFT IN THE SYRINGE. PRODUCT 2/B WAS NOT USED. SAME ARTICLE NUMBER, SAME BATCH NUMBER (AS STATED PREVIOUSLY IN REPORT). UNUSED PACKAGE OF CERAMENT G (PRODUCT 2/B) AND THE SYRINGE WITH THE PARTICLE (PRODUCT 1/A) WERE SENT TO A LABORATORY FOR THE INVESTIGATION. AS WE KNOW FROM RESULTS OF THE LABORATORY INVESTIGATION FOREIGN PARTICLES ARE CONFIRMED TO HAVE THE SAME FTIR SPECTRA AS A PIECE OF MANUALLY CUT RUBBER FROM THE VIAL'S LID. IT IS RELATED TO THE RISK (D.1.2.6) "RUBBER PARTICLES IN THE MIXING LIQUID" WE HAVE NO INFORMATION IF IT WAS ONE PARTICLE OR SEVERAL RUBBER PARTICLES WHICH WERE TOO SMALL AND NON-VISIBLE FOR HUMAN EYE IN THE GENTAMICIN SOLUTION. THEY COULD END UP IN THE FINAL FINISHED FORM AND BE INJECTED TO THE BONE VOID. THE RUBBER PARTICLE IS A FOREIGN BODY, WHICH COULD LEAD OR MIGHT HAVE LED TO COMPLICATIONS IF IMPLANTED. THIS EVENT WAS CONSIDERED AS REPORTABLE TO THE COMPETENT AUTHORITY (BFARM), BSI AND FDA ACCORDING TO RESPECTIVELY REGULATION. RESULTS OF LABORATORY ANALYSIS OF FOREIGN PARTICLES: FOREIGN PARTICLE OF SAMPLE A WAS FOUND IN THE EMPTY SYRINGE, WHILE THE FOREIGN PARTICLE OF SAMPLE B WAS FOUND IN THE VIAL'S SOLUTION. AN INDENTATION MARK FOUND ON THE LID OF SAMPLE A SUGGESTS THAT IS WHERE THE FOREIGN PARTICLE DETACHED FROM (SIMILAR SHAPE AND SIZE). BOTH FOREIGN PARTICLES ARE CONFIRMED TO HAVE THE SAME FTIR SPECTRA AS A PIECE OF MANUALLY CUT RUBBER FROM THE VIAL'S LID. ALTHOUGH A MORE ACCENTUATED BROAD PEAK WAS FOUND IN THE FOREIGN PARTICLE OF SAMPLE B IN THE RANGE OF 3000-3700 CM-1. CONCLUSION FROM LABORATORY: FOREIGN PARTICLES WERE FOUND IN BOTH SAMPLE A AND SAMPLE B. BOTH PARTICLES WERE OF A REDDISH-TONE AND RUBBERY NATURE. FTIR SHOWED THAT THE SPECTRA OF THESE PARTICLES WERE NEARLY IDENTICAL TO THAT OF A MANUALLY CUT PIECE OF THE VIALS' RUBBER LIDS, WHICH SUGGESTS THAT THE PARTICLES MOST LIKELY DETACHED FROM THE RUBBER LID FROM THE PIERCING PROCESS. THE SPECTRA OF THE FOREIGN PARTICLE ON SAMPLE B SHOWED A BROADER AND HIGHER PEAK IN THE REGION OF 3000-3700 CM-1, SUMMARY OF THE BIOCOMPATIBILITY AND SUBSTANCES OF CONCERN DATA FOR THE RUBBER STOPPERS FOR BOTH GENTAMICIN VIAL AND SALINE VIAL: GENTAMICIN VIAL RUBBER STOPPER- (CHLOROBUTYL V9048 FM 140/1 RED 20 MM) GENTAMICIN VIAL RUBBER STOPPER COMPONENT IS COMPLIANT AND TESTED ACCORDING TO: EP 3.2.9 RUBBER CLOSURES FOR CONTAINERS FOR AQUEOUS PARENTERAL PREPARATIONS FOR POWDERS AND FREEZE-DRIED POWDERS USP <381> ELASTOMERIC CLOSURES FOR INJECTIONS USP <87> BIOLOGICAL REACTIVITY TESTS, IN VITRO. SALINE VIAL RUBBER STOPPER - (BROMOBUTYL RUBBER STOPPER 4023/50 20 MM GREY B2-40) SALINE VIAL RUBBER STOPPER COMPONENT IS COMPLIANT AND TESTED ACCORDING TO: ISO 10993-5 USP <381> ELASTOMERIC CLOSURES FOR INJECTION PH. EUR. 3.2.9 RUBBER CLOSURES FOR CONTAINERS FOR AQUEOUS PARENTERAL PREPARATIONS, FOR POWDERS AND FOR FREEZE DRIED POWDERS USP <87> BIOLOGICAL REACTIVITY TESTS, IN VITRO USP <88> BIOLOGICAL REACTIVITY TESTS, IN VIVO (ONLY PERFORMED ON CLOSURES THAT DO NOT MEET USP <87>, PER USP REQUIREMENTS) THE RUBBER STOPPER COMPONENTS CONTAIN NONE OF THE FOLLOWING LISTED SUBSTANCES OF CONCERN: PHTHALATES NATURAL RUBBER (LATEX) ENDOCRINE-DISRUPTING PROPERTIES AT CONCENTRATION LEVELS > 0.1% BY WEIGHT CARCINOGENIC, MUTAGENIC OR TOXIC TO REPRODUCTION (CMR) AT CONCENTRATION LEVELS > 0.1% BY WEIGHT OF CATEGORY 1A OR 1B ALLERGENS THAT COULD RESULT IN SENSITIZATION OR ALLERGIC REACTION SUBSTANCE KNOWN TO THE STATE OF CALIFORNIA PURSUANT TO PROPOSITION 65 TO CAUSE CANCER OR REPRODUCTIVE TOXICITY. GENETICALLY MODIFIED SUBSTANCES (GMO) SUBSTANCES OF VERY HIGH CONCERN (SVHC) AT CONCENTRATION LEVELS > 0.1% BY WEIGHT HEAVY METALS EXCEEDING 100 PPM BY WEIGHT USE OF PROCESSING AGENTS DURING MANUFACTURING LEAVING TRACES > 0.1 % (W/W) LEFT IN THE COMPONENT/ MATERIAL. 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. CONCLUSION: THERE IS AN INCREASED RISK OF ANAPHYLACTOID REACTION, IF RUBBER PARTICLES IN THE MIXING LIQUID ARE INJECTED IN A CONTAMINATED SITE. THE INCIDENT IS DESCRIBED IN THE RISK ASSESSMENT FOR CERAMENT G. IN THIS CASE THERE WAS NO HARM TO THE PATIENT. COMPLAINT SUBCLASS: COMPONENT MALFUNCTION (ANY OF THE COMPONENTS IN THE DEVICE BREAKS OR DOES NOT WORK AS INTENDED). ACTUAL SEVERITY OF EVENT, S=1 (NEGLIGIBLE EFFECT).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON HAD ISSUES WITH TWO CEREMENT G PRODUCTS IN ONE SURGERY. SAME ISSUE WAS DESCRIBED FOR BOTH PRODUCTS; HOWEVER, ONE PRODUCT WAS DISCARDED AND THE OTHER PRODUCT WAS USED (CG 5 ML, A0535-02, MLOT1414 FOR BOTH PRODUCTS). SEE ORIGINAL TEXT RECEIVED IN GERMAN: PRODUCT 1 - A (USED PRODUCT): DER ERSTE SPIKE WURDE IN DAS FLÄSCHCHEN MIT KOCHSALZ GESTECKT. MIT DER LILA SPRITZE WURDE BIS ZUM ROTEN STRICH KOCHSALZ AUFGEZOGEN. DER ZWEITE SPIKE WURDE IN DAS FLÄSCHCHEN MIT DEM GENTAMICIN-PULVER GESTECKT. DIE LILA SPRITZE WURDE KONNEKTIERT UND DAS KOCHSALZ ZUM GENTAMICIN-PULVER ZUGEFÜGT. ALS DAS GENTAMICIN AUFGELÖST WAR, ZEIGTE SICH, DASS IN DER FLÜSSIGKEIT EIN KLEINER PARTIKEL SCHWAMM. DIE SCHWESTER HAT DAS AUFGELÖSTE GENTAMICIN VORSICHTIG AUFGEZOGEN (OHNE PARTIKEL) UND MIT DEM PULVER IN DER MISCHKONSOLE VERMISCHT UND EINE PASTE ANGEFERTIGT. DER PARTIKEL IST IN DER LILA SPRITZE. TRANSLATED TEXT PRODUCT 1: THE FIRST SYRINGE WAS INSERTED INTO THE VIAL CONTAINING SALINE SOLUTION. USING THE PURPLE SYRINGE, SALINE SOLUTION WAS DRAWN UP TO THE RED LINE. THE SECOND SYRINGE WAS INSERTED INTO THE VIAL CONTAINING GENTAMICIN POWDER. THE PURPLE SYRINGE WAS CONNECTED, AND THE SALINE SOLUTION WAS ADDED TO THE GENTAMICIN POWDER. ONCE THE GENTAMICIN HAD DISSOLVED, A SMALL PARTICLE WAS OBSERVED FLOATING IN THE LIQUID. THE NURSE CAREFULLY DREW UP THE DISSOLVED GENTAMICIN (WITHOUT THE PARTICLE) AND MIXED IT WITH THE POWDER IN THE MIXING CONSOLE TO FORM A PASTE. THE PARTICLE IS IN THE PURPLE SYRINGE. PRODUCT 2 -B (NOT USED): DER ERSTE SPIKE WURDE IN DAS FLÄSCHCHEN MIT KOCHSALZ GESTECKT. MIT DER LILA SPRITZE WURDE BIS ZUM ROTEN STRICH KOCHSALZ AUFGEZOGEN. DER ZWEITE SPIKE WURDE IN DAS FLÄSCHCHEN MIT DEM GENTAMICIN-PULVER GESTECKT. DIE LILA SPRITZE WURDE KONNEKTIERT UND DAS KOCHSALZ ZUM GENTAMICIN-PULVER ZUGEFÜGT. ALS DAS GENTAMICIN AUFGELÖST WAR, ZEIGTE SICH, DASS IN DER FLÜSSIGKEIT EIN KLEINER PARTIKEL SCHWAMM. TRANSLATED TEXT PRODUCT 2: THE FIRST SPIKE WAS INSERTED INTO THE VIAL CONTAINING SALINE SOLUTION. USING THE PURPLE SYRINGE, SALINE SOLUTION WAS DRAWN UP TO THE RED LINE. THE SECOND SPIKE WAS INSERTED INTO THE VIAL CONTAINING GENTAMICIN POWDER. THE PURPLE SYRINGE WAS CONNECTED, AND THE SALINE SOLUTION WAS ADDED TO THE GENTAMICIN POWDER. ONCE THE GENTAMICIN HAD DISSOLVED, A SMALL PARTICLE WAS OBSERVED FLOATING IN THE LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2877098 CERAMENT G CERAMENT G QRR BONEUSUPPORT AB A0535-02 MLO1414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female