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MagnetOs 703-057-USRecalls & reported problems

Kuros Biosciences B.V. · MagnetOs Flex Matrix 5.04cc 0.25-1mm Medium · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08719699712171), received between Aug 11, 2026 and Aug 11, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Migration1

Patient problems

  • Limb Pain1
  • Numbness1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 11, 2026Migration

    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

    Patient problems: Limb Pain; Numbness

    MAUDE report 50201933 ↗

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Sources and updates

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