i-FACTOR Peptide Enhanced Bone Graft 700-025Recalls & reported problems
Cerapedics Inc. · i-FACTOR Putty, 2.5cc Syringe · Class 3 · Implant
All models of i-FACTOR Peptide Enhanced Bone Graft (4)
Data updated Oct 18, 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 00850001680011), received between Sep 30, 2025 and Sep 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
1 other recall cover devices cleared under the same FDA submission (P140019); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Neuralgia1
- Neuropathy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2025Migration; Migration
THE PATIENT UNDERWENT A MULTI-LEVEL CERVICAL SPINE FUSION PROCEDURE USING I-FACTOR PEPTIDE ENHANCED BONE GRAFT. POSTOPERATIVELY, THE PATIENT DEVELOPED ACUTE C5 AND C6 RADICULOPATHIES, PRESENTING WITH PAIN AND SIGNS CONSISTENT WITH NEURAL IMPINGEMENT. IMAGING PROVIDED BY THE SURGEON INDICATED POSSIBLE MIGRATION OF GRAFT MATERIAL FROM THE INTENDED SITE, WHICH MAY HAVE CONTRIBUTED TO NERVE ROOT COMPRESSION. THE OPERATIVE REPORT NOTED MECHANICAL NECK PAIN AND ACUTE RADICULOPATHY. WHILE THE EXACT ROOT CAUSE OF THE ADVERSE EVENT CANNOT BE CONCLUSIVELY ATTRIBUTED TO THE DEVICE, GRAFT MIGRATION IS A KNOWN RISK ASSOCIATED WITH BONE GRAFTING PROCEDURES AND IS LISTED IN THE DEVICE'S INSTRUCTIONS FOR USE (IFU). REVISION SURGERY WAS PERFORMED DUE TO THE SEVERITY OF SYMPTOMS, AND THE PATIENT HAS RECOVERED AND IS IMPROVING.
Patient problems: Neuralgia; Neuropathy
MAUDE report 23183597 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140019. One submission often covers many models, so check the product and lot details in each record.
- Z-1056-2022 · Apr 14, 2022 · Terminatedputty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Other Filler, Bone Void, Synthetic Peptide devices
- i-FACTOR Peptide Enhanced Bone Graft 700-010Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide1 recall3 reports
- PearlMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc 730-010Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide1 recall0 reports
- AUGMENT® Injectable K30003010Biomimetic Therapeutics, LLC · Filler, Bone Void, Synthetic Peptide7 reports
- i-FACTOR™ Peptide Enhanced Bone Graft 700-050Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide4 reports
- AUGMENT® Injectable K30001510Biomimetic Therapeutics, LLC · Filler, Bone Void, Synthetic Peptide1 report
- i-FACTOR™ Peptide Enhanced Bone Graft 700-050Cerapedics Inc. · Filler, Bone Void, Synthetic Peptide1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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