i-FACTOR Peptide Enhanced Bone Graft 700-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850001680004), received between Jun 7, 2024 and Nov 26, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 14, 2022Class IIITerminated

   Patient chart label contains incorrect Part Number and volume amount.

   Z-1056-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, A SURGEON REPORTED A SEROMA AFTER THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH BREATHING DIFFICULTIES THREE DAYS POST SINGLE-LEVEL ACDF USING THE I-FACTOR PUTTY PRODUCT. THE QUALITY TEAM FOLLOWED UP WITH THE SURGEON FOR MORE DETAILS. THE SURGEON PROVIDED THE SURGERY DATE, HOSPITAL NAME, PRODUCT LOT NUMBER, AND CONFIRMED NO REVISION SURGERY WAS PERFORMED. ADDITIONAL INFORMATION INCLUDED OTHER PRODUCTS USED DURING THE PROCEDURE AND A CLINICAL NARRATIVE DESCRIBING THE EVENT.

  Patient problems: Dyspnea; Seroma

  MAUDE report 23659322 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, A PATIENT UNDERWENT A C4-C6 FOR LEFT C5 AND C6 CERVICAL RADICULOPATHY AND LEFT C4-5 AND C5-6 FORAMINAL STENOSIS, ASSOCIATED WITH SCAPULAR WINGING, AND PERISCAPULAR PAIN UNRESPONSIVE TO CONSERVATIVE TREATMENT. INTRAOPERATIVELY ". A FULL DISKECTOMY WAS PERFORMED AT C4-5... END PLATES WERE NOW PREPARED AND APPROPRIATELY SIZED INTERBODY CAGE IMPLANT WAS TAMPED INTO PLACE PACKED WITH LOCAL AUTOGRAFT BONE FROM THE OSTEOPHYTE RESECTION AS WELL AS IFACTOR BONE GRAFT ...TITANIUM ANTERIOR FIXATION WAS APPLIED FOR FURTHER STABILIZATION. SECONDARY LOCKING MECHANISM WAS ENGAGED... FULL DISKECTOMY WAS PERFORMED AT C5-6 ... END PLATES WERE NOW PREPARED AND APPROPRIATELY SIZED INTERBODY CAGE IMPLANT WAS TAMPED INTO PLACE PACKED WITH LOCAL AUTOGRAFT BONE FROM THE OSTEOPHYTE RESECTION AS WELL AS IFACTOR BONE GRAFT... TITANIUM ANTERIOR FIXATION WAS APPLIED FOR FURTHER STABILIZATION. SECONDARY LOCKING MECHANISM WAS ENGAGED... " THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, HE CONTACTED THE SURGEON'S OFFICE REPORTING DYSPHAGIA, PARTIAL REGURGITATION OF LIQUIDS, ODYNOPHAGIA, AND HOARSENESS. MUCINEX WAS RECOMMENDED. ON (B)(6) 2025, THE PATIENT REPORTED WORSENING SYMPTOMS

  Patient problems: Dysphagia/ Odynophagia; Dyspnea; Hematoma; Speech Disorder; Vomiting

  MAUDE report 23316315 ↗
• InjuryJun 7, 2024Migration; Migration

  ON THURSDAY, 25 APRIL 2024, EA RECEIVED THE FOLLOWING EMAIL FROM (B)(6), ((B)(6) EMPLOYEE): "EMILY: I TRUST YOU ARE WELL. I RECEIVED A CALL FROM MY DISTRIBUTOR THAT WORKS WITH DR. (B)(6) IN LAKE CHARLES. HE HAS SOME CONCERNS BASED ON RECENT OPERATIVE OUTCOMES "INVOLVING IFACTOR" HE'D LIKE TO DISCUSS THIS WITH SOMEONE TOMORROW AND IS AVAILABLE TOMORROW 10:30 CENTRAL STANDARD TIME. PLEASE LET ME KNOW IF YOU ARE ABLE TO CONNECT WITH HIM SO I CAN MAKE HIM AWARE. THANK YOU IN ADVANCE. CHEERS, (B)(6) REGIONAL SALES MANAGER-SOUTHEAST" EA CALLED DR. (B)(6) ON FRIDAY, 26 APRIL 2024 AS REQUESTED, BUT WAS NOT ABLE TO CONNECT WITH SURGEON. ADDITIONAL INFORMATION RECEIVED ON 13 MAY 2024: ON 13 MAY 2024, EA RECEIVED THE FOLLOWING EMAIL FROM DR. (B)(6) "HI EMILY, 1. PRODUCT INFORMATION: PART NUMBER AND LOT NUMBER / PRODUCT #: 700-010 / LOT #: 23C1770 2. DATE OF EVENT / WEDNESDAY, 04/24/2024 3. DATE OF INITIAL SURGERY / DOS: (B)(6) 2024 4. GLOBUS MEDICAL COLONIAL CAGE, GLOBUS MEDICAL RESONATE PLATE WITH SCREWS 5. PATIENT DEVELOPED SIGNIFICANT PRE VERTEBRAL EDEMA WHICH DYSPHAGIA 6. PATIENT REQUIRED RETURN TO SURGERY FOR WASHOUT OF PRE VERTEBRAL SPACE AND PLACEMENT OF DRAIN. PLEASE CALL ME AT (B)(6)

  Patient problems: Seroma

  MAUDE report 19492703 ↗