MAUDE Adverse Event Report: BONEUSUPPORT AB CERAMENT G

Model Number	A0535-05
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Infiltration into Tissue (1931); Inflammation (1932)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Limited information was reported: sinus and dehiscence 6 weeks post-op of initial placement of 10 ml's of cg.Doctor was taking patient back to or for i.D.Batch number is not known; therefore, it is not possible to perform any batch review.But general trends and complaint data does not indicate any batch-specific issue.More information have been requested from the complainant.
Event or Problem Description
Limited information was reported: sinus and dehiscence 6 weeks post-op of initial placement of 10 ml's of cg.Doctor was taking patient back to or for i.D.Batch number is not known, therefore it is not possible to perform any batch review.But general trends and complaint data does not indicate any batch-specific issue.More information have been requested from the complainant.
Additional Manufacturer Narrative
Limited information was reported: sinus and dehiscence 6 weeks post-op of initial placement of 10 ml's of cg.Doctor was taking patient back to or for i.D.Batch number is not known, therefore it is not possible to perform any batch review.But general trends and complaint data does not indicate any batch-specific issue.The information provided related to the incident was too limited.Questions like patient characteristics, age, type of surgery, tests/laboratory data, radiographs etc.Cannot be answered.Due to the limited information provided, it is not possible to conduct a medical investigation at this time.Sinus formation and wound dehiscence may be considered potential complications of any surgical procedure.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.
Event or Problem Description
Limited information was reported: sinus and dehiscence 6 weeks post-op of initial placement of 10 ml's of cg.Doctor was taking patient back to or for i.D.Batch number is not known, therefore it is not possible to perform any batch review.But general trends and complaint data does not indicate any batch-specific issue.No further information was received regarding the batch.

• Brand Name: CERAMENT G
• Common Device Name: CERAMENT G
• Manufacturer (Section D): BONEUSUPPORT AB; scheelevägen 19; ideon science park; lund, 22370 ; SW 22370
• Manufacturer (Section G): BONESUPPORT AB; scheelevägen 19; ideon science park; lund, 22370 ; SW 22370
• Manufacturer Contact: fareda håkansson ; scheelevägen 19; ideon science park; lund, 22370 ; SW 22370
• MDR Report Key: 24331659
• Report Number: 3005304945-2026-00001
• Device Sequence Number: 18591712
• Product Code: QRR
• UDI-Device Identifier: 07350055430523
• UDI-Public: 07350055430523
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K234008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: A0535-05
• Device Catalogue Number: A0535-05
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Hospitalization
• Patient Sex: Unknown