MAUDE Adverse Event Report: BONESUPPORT AB CERAMENT BONE VOID FILLER

Model Number	A0210-11
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Encephalopathy (1833); Embolism/Embolus (4438)
Date of Event	11/19/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Mlot1331 (a0210-11, cerament bone void filler 18 ml), manufacturing date: 05/28/2024, expiration date: 11/23/2027.Manufacturer batch investigation: review of batch records for mlot1331 including quality release results has been performed.All results from release tests were within limits.The first device from the batch was sold on 06/04/2024.(b)(4) devices of the total batch size of (b)(4) devices have been sold.No other complaints have been received for the batch.From the instructions for use for cerament bvf: indications for use: cerament bone void filler is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.Cerament bone void filler is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.E.Extremities, pelvis, and poste- rolateral spine (only during open surgery in spine).These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients 9 years old and older), or osseous defects created as a result of either surgery or traumatic injury to the bone.Cerament bone void filler resorbs and is replaced by bone during the healing process.Cerament bone void filler can augment hardware and support bone fragments during the surgical procedure.The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.Cerament bone void filler can be drilled and screws can be placed through it.The product was used on a 7 year old, meaning it is off-label use.
Event or Problem Description
On 12/02/2024 a bonesupport employee was made aware of the event.The current provided information is still limited, and we are still awaiting additional information.From observation form provided by distributor: acute cardiac arrest due to synthetic bone graft embolization with subsequent hypoxemia/ anoxic brain injury/ fatality.Care withdrawn after brain death confirmed (b)(6) 2024.
Event or Problem Description
On 12/02/2024 a bonesupport employee was made aware of the event.The current provided information is still limited, and we are still awaiting additional information.From observation form provided by distributor: acute cardiac arrest due to synthetic bone graft embolization with subsequent hypoxemia/ anoxic brain injury/ fatality.Care withdrawn after brain death confirmed (b)(6) 2024.Added on 14th february 2025: summarizing the available reports from the hospital, an aneurysmal bone cysts (abc) in the left proximal tibia was discovered in a 7-year-old patient.The surgical intervention was started with a bone biopsy, followed by filling the cyst with the radiocontrast agent optimark dye, sclerotherapy using doxycycline, human albumin and percutaneous filling of the abc with 54 cc cerament bone void filler via three jamshidi needles.Shortly after injection of cerament bone void filler diffuse st elevations followed by bradycardia and pulseless electrical activity were noticed.Immediately pediatric advanced life support was started, and patient was connected to extracorporeal membrane oxygenation.Despite treatment on the pediatric intensive care unit, the patient passed away on (b)(6) 2024.According to hospital, cause of death: bone graft material embolization leading to cardiac arrest and hypoxic-ischemic encephalopathy (hie).
Additional Manufacturer Narrative
Mlot1331 (a0210-11, cerament bone void filler 18 ml), manufacturing date: 05/28/2024, expiration date: 11/23/2027.Manufacturer batch investigation: review of batch records for mlot1331 including quality release results has been performed.All results from release tests were within limits.The first device from the batch was sold on 06/04/2024.(b)(4) devices of the total batch size of (b)(4) devices have been sold.No other complaints have been received for the batch.From the instructions for use for cerament bvf: indications for use: cerament bone void filler is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.Cerament bone void filler is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.E.Extremities, pelvis, and poste- rolateral spine (only during open surgery in spine).These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients 9 years old and older), or osseous defects created as a result of either surgery or traumatic injury to the bone.Cerament bone void filler resorbs and is replaced by bone during the healing process.Cerament bone void filler can augment hardware and support bone fragments during the surgical procedure.The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.Cerament bone void filler can be drilled and screws can be placed through it.The product was used on a 7 year old, meaning it is off-label use.Added on 14th february 2025: the intraoperative symptoms shortly after sclerotherapy and percutaneous injection of cerament bone void filler in combination with the later findings in the ct scan of the thorax point to a syndrome similar to the "bone cement implantation syndrome (bcis)".Bone cement implantation syndrome (bcis) is an established clinical syndrome which orthopaedic surgeons and anesthetists are aware of.According to the surgical notes from the hospital, bone biopsy and surgical treatment of the abc were done in one setting.Based on general recommendations biopsy should be done before treatment to rule out the main differential diagnosis of an abc in the pediatric population (unicameral bone cyst (ubc) and telangiectatic osteosarcoma).From the surgical notes, after sclerotherapy with different agents (doxycycline mixed with human albumin and agitated with air), cerament bone void filler was injected into the abc percutaneously via three jamshidi needles.However, the combination of sclerotherapy with percutaneous injection of a bone void filler was not found in the reviewed literature.The information provided by the hospital indicates that the instructions for use have not been followed at several points according to below: 1)the patient was 7 years old.Cerament bone void filler is not indicated in the age group younger than 9 years.This is considered as an off-label use.2) according to the ifu, "overpressurization during injection should be avoided as intra-medullar injection with any bone void filler may lead to fat embolization or embolization of cerament bone void filler into the blood stream." and "overpressurization of the device may lead to extrusion of the device beyond the site of its intended application and damage the surrounding tissues." the surgeon describes in the procedure note that jamshidi needles have been used to vent the abc and to release the pressure.This technique has been described for ubc, which do not have many chambers or membranes / septae.In abc, the venting needles can easily be blocked by free-floating membranes or only vent one of the several chambers of the multi-cameral abc.Overpressurization has probably led to the embolization of cerament bone void filler into the bloodstream.3) according to the ifu "in aneurysmal bone cysts (abcs) and other bone cysts prone to producing large volumes of fluid, there is increased risk of wound drainage, soft-tissue inflammation and wound breakdown if treated by open surgery.Use cerament bone void filler in bead form rather than complete void filling for these indications." in the procedural notes it is mentioned that the product was injected as a paste and not used in bead form.4) according to the ifu "using alternative mixing solutions and/or adding other substances to cerament bone void filler may affect the product setting in an uncontrolled manner and may affect the safety and effectiveness of the product.".In the procedural notes it is described that mixture of doxycycline with human albumin and agitated with air was injected into the cystic lesion, followed mixing cerament "and sequentially injected into all of the jamshidi needles and were vented x 5 min and the needles were removed".The chemical and physical interactions between cerament bone void filler, doxycycline and albumin are not known, but may have affected the product setting in an uncontrolled manner and the safety and effectiveness of the product.5) according to the ifu, "inject carefully under visual inspection or radiographic monitoring to avoid spreading of product outside of the intended injection site".It can be stated, this precaution was not followed, because a significant amount of the product was visible in the ct-scan of the thorax.Product evaluation: review of batch records for mlot1331 including quality release results has been performed.All results from release tests were within limits.The first device from the batch was sold on 06/04/2024.(b)(4) devices of the total batch size of (b)(4) devices have been sold.No other complaints have been received for the batch.Conclusion: the product has been used off label, meaning that precautions related to aneurysmal bone cysts, indications and directions for use in the instructions for use have not been followed.The adverse event has not led to any new risks having been identified which are not already described in the precautions and directions for use in the instructions for use.The product is not defect and it has not malfunctioned.

• Brand Name: CERAMENT BONE VOID FILLER
• Common Device Name: CERAMENT BONE VOID FILLER
• Manufacturer (Section D): BONESUPPORT AB; scheelevagen 19; ideon science park; lund, 22370 SWE; SW 22370 SWE
• Manufacturer (Section G): BONESUPPORT AB; scheelevägen 19; ideon science park; lund, swe, 22370 SWE; SW 22370 SWE
• Manufacturer Contact: fareda håkansson ; scheelevägen 19; ideon science park; lund, lund, swe 22370 ; SW 22370
• MDR Report Key: 20964804
• Report Number: 3005304945-2024-00005
• Device Sequence Number: 8261179
• Product Code: MQV
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K201535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A0210-11
• Device Catalogue Number: A0210-11
• Device Lot Number: MLOT1331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 29 KG