i-FACTOR Peptide Enhanced Bone GraftRecalls & reported problems across all models

We found 4 models of i-FACTOR Peptide Enhanced Bone Graft by Cerapedics Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2019 and Nov 26, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (5 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

i-FACTOR Peptide Enhanced Bone Graft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 14, 2022Terminated

   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 i-FACTOR Peptide Enhanced Bone Graft problems

i-FACTOR Peptide Enhanced Bone Graft models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• i-FACTOR Peptide Enhanced Bone Graft 700-010

  Filler, Bone Void, Synthetic Peptide
  1 recall3 reports
• i-FACTOR™ Peptide Enhanced Bone Graft 700-050

  Filler, Bone Void, Synthetic Peptide
  4 reports
• i-FACTOR Peptide Enhanced Bone Graft 700-025

  Filler, Bone Void, Synthetic Peptide
  1 report
• i-FACTOR™ Peptide Enhanced Bone Graft 700-050

  Filler, Bone Void, Synthetic Peptide
  1 report

Recent i-FACTOR Peptide Enhanced Bone Graft adverse event reports

The 9 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionJan 6, 2025

  UNKNOWN WHITE MILKY LIQUID INSIDE THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078897 ↗
• 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 ↗
• 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 ↗
• 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 ↗