MAUDE Adverse Event Report: Kuros Biosciences B.V MagnetOs MIS; Filler, Bone Void, Calcium Compound

Catalog Number	703-060-US
Medical Device Problem Codes	Fracture (1260); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction

• Brand Name: MagnetOs MIS
• Common Device Name: Filler, Bone Void, Calcium Compound
• Manufacturer (Section D): Kuros Biosciences B.V; professor bronkhorstlaan 10; bilthoven, ut 3723M B; NL 3723MB
• Manufacturer Contact: marcel borger ; professor bronkhorstlaan 10; bilthoven, utrecht 3723M-B ; NL 3723MB
• MDR Report Key: 50013772
• Report Number: 3008147766-2026-00014
• Device Sequence Number: 21225664
• Product Code: MQV
• UDI-Device Identifier: 08719699712201
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K243474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 703-060-US
• Device Lot Number: U3472
• 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: 06/22/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown