MAUDE Adverse Event Report: BONESUPPORT AB CERAMENT BONE VOID FILLER

Model Number	A0210-08
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Infiltration into Tissue (1931); Inflammation (1932); Post Operative Wound Infection (2446)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mlot0983 (a0210-08, cerament bone void filler), manufacturing date:10/20/2022, expiration date: 12/11/2025.Manufacturer batch investigation: review of batch records for mlot0983 including quality release results has been performed.All results from release tests were within limits.The first device from the batch was sold in 10/31/2022, (b)(4) devices of the total batch size of (b)(4) devices have been sold.The medical investigation of the complaint will be submitted in a follow-up report after recieving additional data from the responsible physician.
Event or Problem Description
Post-operatively the incision healed nicely then weeks later the incision opened and started draining liquid cerament.On second operation, all of the cerament within the cavity was liquid - not solid.Return to operating room to remove cerament and re-close the incision.Unnecessary anesthesia, cost of re-operation.Enterobacter cloacae complex infection due to open wound requiring infectious disease consult, iv followed by long term po antibiotics.Significant delay in patient's ability to return to activity.
Additional Manufacturer Narrative
Mlot0983 (a0210-08, cerament bone void filler), manufacturing date:10/20/2022, expiration date: 12/11/2025.Manufacturer batch investigation: review of batch records for mlot0983 including quality release results has been performed.All results from release tests were within limits.The first device from the batch was sold in 10/31/2022, (b)(4) devices of the total batch size of (b)(4) devices have been sold.The medical investigation of the complaint will be submitted in a follow-up report after receiving additional data from the responsible physician.This information was added on 19th june 2024: additional information was received from the surgeon 24th april 2024, thereafter a medical investigation was performed.Conclusion of the medical device: the information to this complaint is sufficient to draw some conclusions.The reported case is off label use since the age of the patient less than 9 years old."white drainage" is a well-known occurrence in calcium-based bone void fillers.The incident considered is an expected and foreseeable effect which was described in the risk assessment and in the instructions for use for cerament bone void filler.Usually, surgical revision is not necessary in the absence of signs of recurrent infection.However, in this case the wound was infected, and reoperation needed.We also received information that the wound healed.See attachment for complete medical investigation report.
Event or Problem Description
Post-operatively the incision healed nicely then weeks later the incision opened and started draining liquid cerament.On second operation, all of the cerament within the cavity was liquid - not solid.Return to operating room to remove cerament and re-close the incision.Unnecessary anesthesia, cost of re-operation.Enterobacter cloacae complex infection due to open wound requiring infectious disease consult, iv followed by long term po antibiotics.Significant delay in patient's ability to return to activity.
Event or Problem Description
Post-operatively the incision healed nicely then weeks later the incision opened and started draining liquid cerament.On second operation, all of the cerament within the cavity was liquid - not solid.Return to operating room to remove cerament and re-close the incision.Unnecessary anesthesia, cost of re-operation.Enterobacter cloacae complex infection due to open wound requiring infectious disease consult, iv followed by long term po antibiotics.Significant delay in patient's ability to return to activity.
Additional Manufacturer Narrative
Mlot0983 (a0210-08, cerament bone void filler), manufacturing date:10/20/2022, expiration date: 12/11/2025.Manufacturer batch investigation: review of batch records for mlot0983 including quality release results has been performed.All results from release tests were within limits.The first device from the batch was sold in 10/31/2022, (b)(4) devices of the total batch size of (b)(4) devices have been sold.The medical investigation of the complaint will be submitted in a follow-up report after recieving additional data from the responsible physician.This information was added on 19th june 2024: additional information was received from the suregon 24th april 2024, thereafter a medical investigation was performed.Conclusion of the medical device: the information to this complaint is sufficient to draw some conclusions.The reported case is off label use since the age of the patient less than 9 years old."white drainage" is a well-known occurrence in calcium-based bone void fillers.The incident considered is an expected and foreseeable effect which was described in the risk assessment and in the instructions for use for cerament bone void filler.Usually, surgical revision is not necessary in the absence of signs of recurrent infection.However, in this case the wound was infected, and reoperation needed.We also received information that the wound healed.See attachment for complete medical investigation report.This information was added on the 10th july 2024: investigations are still ongoing at bonesupport within capa-0166 as referred above.
Additional Manufacturer Narrative
The root-cause investigation concluded that deviations were made from ifu0007-12 for this case.The indication for cerament bvf (see ifu0007) is: 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 posterolateral 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.In this case the product was used on a 7-year-old, hence the product has been used off-label.

• Brand Name: CERAMENT BONE VOID FILLER
• Common Device Name: CERAMENT BONE VOID FILLER
• Manufacturer (Section D): BONESUPPORT AB; scheelevägen 19; ideon science park; lund, 223 7 0 SW; SW 223 70 SWE
• Manufacturer (Section G): BONESUPPORT AB; scheelevägen 19; ideon science park; lund, 22370 SWE; SW 22370 SWE
• Manufacturer Contact: fareda khalil ; scheelevägen 19; ideon science park; lund, 22370- SWE ; SW 22370 SWE
• MDR Report Key: 19189458
• Report Number: 3005304945-2024-00003
• Device Sequence Number: 12852298
• Product Code: MQV
• UDI-Device Identifier: 07350055430035
• UDI-Public: 07350055430035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/29/2024

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 Expiration Date: 12/11/2025
• Device Model Number: A0210-08
• Device Catalogue Number: A0210-08
• Device Lot Number: MLOT0983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 03/29/2024; 03/29/2024; 03/29/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/20/2024; 07/10/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 22 KG