Permatage 5cc OS-PER-1001Recalls & reported problems
Abyrx, Inc. · Class U · 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 00850391007238), received between May 20, 2025 and May 20, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ABYRX RECEIVED COMMUNICATION REGARDING A USE IN CANADA OF THE PERMATAGE¿ SETTABLE, NONABSORBABLE BONE PUTTY IN THE TREATMENT OF A SEGMENTAL DEFECT OF THE DISTAL TIBIA. THE DEVICE WAS REPORTEDLY USED TO FILL A SEGMENTAL BONE DEFECT, WITHOUT ANY SUPPLEMENTAL FIXATION FOR STABILIZATION OF PERMATAGE IN THE PROCEDURE. SUBSEQUENTLY, THE PATIENT PRESENTED WITH DISLODGEMENT OF THE DEVICE FROM THE APPLICATION SITE. THE USE DID NOT APPEAR TO BE IN ACCORDANCE WITH THE LABELING FOR THE DEVICE OR APPROPRIATE MEDICAL PRACTICES. ABYRX CONFIRMED WITH THE SALES REPRESENTATIVE THAT THE DEVICE'S INSTRUCTIONS FOR USE (IFU) HAD BEEN PROVIDED TO THE OPERATING SURGEON PRIOR TO THE PROCEDURE. THE PROCEDURE ITSELF WAS A REVISION OF A PREVIOUSLY FAILED TOTAL ANKLE IMPLANT. FURTHER DETAILS REGARDING THE PRIMARY PROCEDURE WERE NOT PROVIDED. THE BATCH RECORD FOR THE DEVICE LOT WAS REVIEWED IN ITS ENTIRETY, INCLUDING ALL DOCUMENTED STEPS OF MANUFACTURING, STERILIZATION, STERILE BARRIER INTEGRITY VERIFICATION, AND FINAL RELEASE TESTING. ALL RECORDS WERE FOUND TO BE COMPLETE AND COMPLIANT WITH ESTABLISHED PROCEDURES AND SPECIFICATIONS. THERE WERE NO DISCREPANCIES, DEVIATIONS, OR CONCERNS NOTED. THE LOT MET ALL AP
Patient problems: Implant Pain
MAUDE report 22055699 ↗
Other Wax, Bone devices
- ETHICON W31GEthicon, LLC · WAX,BONE20 reports
- Bone Wax BW25GCovidien LP · WAX,BONE3 reports
- Montage 5cc OS-MON-1001Abyrx, Inc. · Wax,Bone2 reports
- Montage 2cc Multipack OS-MON-1604Abyrx, Inc. · Wax,Bone1 report
- MEDLINE INDUSTRIES DYNJBW25Medline Industries, Inc. · Wax, bone1 report
- MEDLINE BONEWAX YELLOW DYNJBW25Surgical Specialties México, S. de R.L. de C.V. · WAX,BONE1 report
- ETHICON DW31BEthicon Inc. · WAX,BONE1 report
- Ssc Bone Wax 901Surgical Specialties México, S. de R.L. de C.V. · WAX,BONE1 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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