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

Catalog Number	703-057-US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Numbness (2415); Limb Pain (4836)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported the following: "on (b)(6) 2023, a l4-5 bilateral interlaminar decompression and foraminotomy, l4-5 transforaminal lumbar interbody fusion, intervertebral cage, nonsegmental fixation, synthetic bone graft, autogenous bone graft, and posterolateral fusion on patient was performed.(b)(6) 2023 a ct lumbar spine was performed and showed some graft material from the intervertebral disc space had fallen into the neural canal on the left side.(b)(6) 2023 a redo re-exploration of the left l4/5, discectomy, foraminotomy, and additional stabilization with pedicle screw and rod fixation was performed." the surgeon further reported that the patient developed postoperative weakness and numbness with recurrent leg pain.The surgeon has implanted both magnetos flex matrix and magnetos easypack putty.Available information reasonably suggests that the synthetic bone graft may have caused or contributed to a serious injury because the graft migrated into the neural canal and resurgery / revision surgery was required.Therefore, this cases is considered reportable.Note that this case is being reported outside the applicable reporting timeframe.Following an observation identified during a recent mdsap audit, historical complaints are being reassessed for reportability, which led to the identification and submission of this case.

• Brand Name: MagnetOs Flex Matrix
• Common Device Name: Filler, Bone Void, Calcium Compound
• Manufacturer (Section D): Kuros Biosciences B.V.; prof. bronkhorstlaan 10; bilthoven, ut 3723 MB; NL 3723 MB
• Manufacturer Contact: marcel borger ; prof. bronkhorstlaan 10; bilthoven, ut 3723 -MB ; NL 3723 MB
• MDR Report Key: 50201933
• Report Number: 3008147766-2026-00091
• Device Sequence Number: 12142779
• Product Code: MQV
• UDI-Device Identifier: 08719699712171
• UDI-Public: 08719699712171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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 Catalogue Number: 703-057-US
• Device Lot Number: O2309
• 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: 10/04/2024
• Initial Report FDA Received Date: 08/11/2026
• 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: Required Intervention
• Patient Sex: Unknown