i-FACTOR™ Peptide Enhanced Bone Graft 700-050 (UDI 00850001680028)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850001680028), received between Mar 11, 2024 and Jan 6, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025

  UNKNOWN WHITE MILKY LIQUID INSIDE THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078897 ↗
• InjuryMar 12, 2024Migration; Migration

  PATIENT PRESENTED WITH MIGRATION OF THE BONE VOID FILLER FROM THE GRAFT SITE, RESULTING IN PATIENT PAIN AND DYSPHAGIA. PATIENT CONTACTED CERAPEDICS AFTER CLOSURE OF C22-110 COMPLAINING OF ON-GOING NECK PAIN NEAR C7 ON THE LEFT LOWER SIDE STATING THAT THEY HAVE GOTTEN 4 CT SCANS IN LESS THAN 28 MOS AND SEVERAL OTHER TESTS. THE CT RESULTS REMAIN UNCHANGED.

  Patient problems: Pain

  MAUDE report 18886676 ↗
• InjuryMar 12, 2024Migration; Migration

  SURGEON INITIALLY SAW THE PATIENT ON (B)(6) 2023 FOR A SCHEDULED 2-LEVEL ACDF AT C3/C5. NO ADVERSE EVENTS OCCURRED DURING SURGERY AND PATIENT PRESENTED WITH NO COMPLICATIONS IMMEDIATELY POST-OP. THE PATIENT RETURNED TO SURGEON'S OFFICE ON (B)(6) 2023, 5 DAYS POST-OP WITH SIGNIFICANT ANTERIOR AND LEFT TRACHEAL SWELLING WITH TENDERNESS TO PALPATION. THE PATIENT'S DIFFICULTY SWALLOWING RAISED CONCERN AS THE PATIENT WAS UNABLE TO EAT OR DRINK ANYTHING INCLUDING WATER. THE PATIENT WAS SENT DIRECTLY BACK TO DELRAY MEDICAL CENTER EMERGENCY ROOM FOR ADMISSION. CERVICAL A/P AND LATERAL X-RAYS SHOW SIGNIFICANT PRE-VERTEBRAL SWELLING WITH ANTERIOR C2-C7 DISPLACEMENT (27MM) OF THE TRACHEA WITHOUT DISPLACEMENT FROM MIDLINE.

  Patient problems: Swelling/ Edema

  MAUDE report 18886502 ↗
• InjuryMar 11, 2024Migration; Migration

  PATIENT PRESENTED WITH MIGRATION OF THE BONE VOID FILLER FROM THE GRAFT SITE, RESULTING IN PATIENT PAIN AND DSYPHAGIA. PATIENT HAD AN UPPER ESOPHAGEAL PROCEDURE TO DILATE HER ESOPHAGUS.

  Patient problems: Implant Pain

  MAUDE report 18882629 ↗

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