i-FACTOR™ Peptide Enhanced Bone Graft 700-050 (UDI M8517000501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M8517000501), received between Nov 14, 2019 and Nov 14, 2019 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

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

• InjuryNov 14, 2019Appropriate Device Problem Term/Code Not Available

  INTERBODY FUSION WAS PERFORMED USING I-FACTOR + ALLOGRAFT. IT WAS PACKED INSIDE THE DISC SPACE FROM RIGHT SIDE WITHOUT A CAGE AS DISC SPACE WAS NARROW AND THERE WAS OSTEOPOROSIS. 30 HOURS AFTER SURGERY, THE PATIENT WALKED IN THE HALLWAY AND SHE DEVELOPED PROGRESSIVELY WORSENING FOOT DROP. CT AND MRI SHOWED THIS WAS SECONDARY TO I-FACTOR AS IT RETROPULSED INTO THE SPINAL CANAL ON THE LEFT SIDE (OPPOSITE THE SIDE IT WAS INTRODUCED). THE ALLOGRAFT WAS AN UNKNOWN BRAND OF CANCELLOUS ALLOGRAFT. REMEDIAL ACTION BY THE SURGEON INCLUDED REVISION SURGERY FOR REMOVAL OF THE I-FACTOR FROM THE SPINAL CANAL AROUND THE LEFT L5 NERVE ROOT. THE SURGERY RESULTED WITH PROMPT SENSORY RETURN AND SLOW IMPROVEMENT OF FOOT DROP.

  Patient problems: Nerve Damage

  MAUDE report 9321330 ↗

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 · Terminated
  putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY