Avitene 1010020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741000386), received between Jul 12, 2017 and Jun 9, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A PROCEDURE WITH USAGE OF AVITENE, AFTER WHICH A GRANULOMA WAS FOUND. CLEANING WAS PERFORMED AFTER PLACING THE AVITENE AND HEMOSTASIS ACHIEVED. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY BEING TREATED.

  Patient problems: Granuloma

  MAUDE report 22168198 ↗
• MalfunctionDec 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A BLACK FOREIGN OBJECT WAS FOUND IN THE AVITENE IN AN UNOPENED STATE BEFORE USE. IT WAS REPORTED THAT THERE WAS NO SIGN OF PACKAGE DAMAGE FOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000994 ↗
• InjuryJun 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER MEDWATCH REPORT (MW5154685): ON OR ABOUT (B)(6) 2020 A DEPUY SPINAL WAS USED IN PATIENT SURGERY. UPON INFORMATION, THE PRODUCT USED IN PATIENT SURGERY INCLUDE DEPUY EXPEDIUM, COBALT CHROMIUM RODS, UNIAXIAL PEDICEL SCREWS, DEPUY SPINE SCREWS, ROD VIPER STRAIGHT AND OR OTHER ASSOCIATED DEVICES. THE PATIENT HAD SOME PAIN POSTOPERATIVELY AND ALSO HAD DESCRIPTIONS OF CRACKING AND POPPING INVOLVING HER LUMBOSACRAL SPINE. X-RAY REVEALED A DISENGAGEMENT OF THE LEFT-SIDED ROD FROM HER L3 PEDICLE SCREW AND THE PATIENT'S CORONAL BALANCE ALSO APPEARED TO BE SIGNIFICANTLY AFFECTED. PATIENT WAS CAUSED TO SUSTAIN SEVERE, SERIOUS, PERMANENT INJURIES THAT HAD RENDERED HER SICK LORE, LAME AND DISABLED. ALSO NOTED THE PATIENT EXPERIENCED NECROSIS. ON (B)(6) 2020 THE PATIENT UNDERWENT REINSERTION OF SPINAL FIXATION DEVICE WITH REVISION OF INSTRUMENTATION DUE TO POSTERIOR INSTRUMENTED SPINAL FUSION HARDWARE FAILURE. ON (B)(6) 2020 THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF SKIN INCLUDING THE SUBCUTANEOUS LEVEL AND FASCIA, RIGHT SIDE AND LEFT SIDE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)." NOTE: THE COMPLAINT REPORTED FAILURE OF SPINAL I

  Patient problems: Necrosis

  MAUDE report 19520170 ↗
• InjuryJun 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER MEDWATCH REPORT (MW5154686): ON OR ABOUT (B)(6) 2020 A DEPUY SPINAL WAS USED IN PATIENT SURGERY. UPON INFORMATION, THE PRODUCT USED IN PATIENT SURGERY INCLUDE DEPUY EXPEDIUM, COBALT CHROMIUM RODS, UNIAXIAL PEDICEL SCREWS, DEPUY SPINE SCREWS, ROD VIPER STRAIGHT AND OR OTHER ASSOCIATED DEVICES. THE PATIENT HAD SOME PAIN POSTOPERATIVELY AND ALSO HAD DESCRIPTIONS OF CRACKING AND POPPING INVOLVING HER LUMBOSACRAL SPINE. X-RAY REVEALED A DISENGAGEMENT OF THE LEFT-SIDED ROD FROM HER L3 PEDICLE SCREW AND THE PATIENT'S CORONAL BALANCE ALSO APPEARED TO BE SIGNIFICANTLY AFFECTED. PATIENT WAS CAUSED TO SUSTAIN SEVERE, SERIOUS, PERMANENT INJURIES THAT HAD RENDERED HER SICK LORE, LAME AND DISABLED. ALSO NOTED THE PATIENT EXPERIENCED NECROSIS. ON (B)(6) 2020 THE PATIENT UNDERWENT REINSERTION OF SPINAL FIXATION DEVICE WITH REVISION OF INSTRUMENTATION DUE TO POSTERIOR INSTRUMENTED SPINAL FUSION HARDWARE FAILURE. ON (B)(6) 2020 THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF SKIN INCLUDING THE SUBCUTANEOUS LEVEL AND FASCIA, RIGHT SIDE AND LEFT SIDE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)". REFERENCE REPORT MW5154685. NOTE: THE COMPLAINT

  Patient problems: Necrosis

  MAUDE report 19520166 ↗
• InjuryDec 8, 2023Off-Label Use; Off-Label Use

  AS REPORTED, THE PATIENT UNDERWENT THE ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2023. AVITENE FLOUR 1 GRAM MIXED WITH SALINE AND THROMBIN WAS USED (OFF LABEL PER IFU). THE SURGEON LEFT EXCESS AVITENE IN AND SEEPED INTO THE EPIDURAL SPACE LEADING TO SPINAL CORD COMPRESSION. POST USAGE PATIENT EXPERIENCED PAIN AND WEAKNESS IN ARM AND UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2023 WHICH INCLUDED A CORPECTOMY. NO OTHER HEMOSTATIC AGENTS OR PRODUCTS WERE USED.

  Patient problems: Intervertebral Disc Compression or Protrusion

  MAUDE report 18291237 ↗
• MalfunctionMay 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, DURING PREPARATION OF THE BARD/DAVOL AVITENE FLOUR WITH SALINE SOLUTION, A HAIR-LIKE FOREIGN MATERIAL WAS FOUND. THERE WAS NO DAMAGE NOTICED ON THE OUTER PACKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14318401 ↗
• MalfunctionJul 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE MEDICAL STAFF OPENED THE TRAY OF BARD AVITENE FLOUR, A PIECE OF FOREIGN MATTER WAS NOTED TO BE IN THE FLOUR. UPON RECEIPT OF THE SAMPLE IT WAS NOTED THAT THE FOREIGN MATERIAL WAS A SMALL METAL FRAGMENT. THIS FRAGMENT COULD PRESENT AS A HARM TO THE PATIENT IF IT HAD GONE UNDETECTED OR HAD BEEN LEFT IN THE PATIENT FOLLOWING USE OF THE PRODUCT. THEREFORE THIS MDR IS FILED TO DOCUMENT THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6706739 ↗