OSferion AR-13370-4Recalls & reported problems
Osferionbiomaterials Corp. · OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSferion is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The porosity of OSferion is 60%. Products are supplied in wedges and trapezoids. · Class 2 · Implant
Data updated Oct 13, 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 04560245656913), received between Apr 28, 2026 and Apr 28, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2026Use of Device Problem
BASED ON INFORMATION PROVIDED BY ARTHREX, INC., IT WAS REPORTED THAT DURING A HIGH TIBIAL OSTEOTOMY PROCEDURE, ARTHREX, INC.- MANUFACTURED CANCELLOUS SCREWS WERE FOUND BROKEN DURING A POST-OPERATIVE FOLLOW-UP. THE PATIENT HAS COMPLAINED OF A SENSATION OF INSTABILITY BUT DOES NOT REPORT A SPECIFIC EVENT OR TIME FRAME IN WHICH THE INSTABILITY STARTED. THREE (3) AR-13370-4 "OSFERION" (OSTEOTOMY WEDGES) MANUFACTURED BY OUR COMPANY WERE ALSO IMPLANTED DURING THE SAME PROCEDURE. REVISION SURGERY WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE BROKEN SCREWS AND ASSOCIATED IMPLANTED COMPONENTS, INCLUDING THE THREE (3) AR-13370-4 "OSFERION" (OSTEOTOMY WEDGES), WERE EXPLANTED. THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2022, AND REVISION SURGERY OCCURRED ON (B)(6) 2023. BOTH THE INITIAL PROCEDURE AND THE REVISION SURGERY WERE PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON. ACCORDING TO THE INFORMATION RECEIVED, POST-OPERATIVE X-RAY IMAGES WERE REVIEWED AS PART OF THE EVALUATION BY ARTHREX, INC., AND BASED ON THE INFORMATION AVAILABLE, THE EVENT WAS CONCLUDED TO BE MOST LIKELY ATTRIBUTABLE TO A PATIENT-SPECIFIC FACTOR.
Patient problems: Failure of Implant
MAUDE report 25011412 ↗
Other Filler, Bone Void, Calcium Compound devices
- 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) T42275Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls1 report
- 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) T42200Medtronic 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
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- HydroSet XT 897003Stryker 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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