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
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 ↗
Other FILLER, BONE VOID, CALCIUM COMPOUND devices
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42275Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44150Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42280Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- HydroSet XT 897005Stryker Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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