SURGICEL FIBRILLAR 1963Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705031003132), received between Dec 26, 2017 and Sep 17, 2026 — classified as 39 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Jun 11, 2024Class IIOpen, Classified

   Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

   Z-2407-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Tibial osteotomy procedure on (b)(6) 2026 and absorbable hemostat was used. Hemostatic gauze were used for local hemostasis during surgery. More than 40 days after surgery, there was pain and discomfort in the surgical area, but symptomatic treatment did not improve. The patient was admitted to the hospital with cellulitis of the right calf. After admission, symptomatic treatments such as anti infection, anti-inflammatory, and wound drainage were given, and purulent secretions from the wound were cleared in stages until the inflammatory indicators and symptoms of the affected limb gradually improved. During hospitalization, the patient's condition remained stable and the infection was completely controlled. Prior to discharge, a dressing change was made at the incision site, and the patient's condition recovered. The patient was discharged. Additional information was requested

  Patient problems: Cellulitis; Discomfort; Inflammation; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 50802257 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. AFTER THE PATIENT WAS ADMITTED, RELEVANT EXAMINATIONS WERE COMPLETED AND SURGICAL CONTRAINDICATIONS WERE RULED OUT. THE SURGERY WAS PERFORMED FROM 10:55 TO 12:15. DURING THE SURGERY, KNEE JOINT COMPONENTS SUCH AS FEMORAL IMPLANTS, HEMOSTATIC GAUZE, AND HEMOSTATIC FLUID GELATIN WERE USED. NO ABNORMALITIES WERE FOUND DURING THE USE, AND THE PLACEMENT WAS SMOOTH. THE PATIENT HAD GOOD POSTOPERATIVE RECOVERY AND WAS DISCHARGED. REGULAR FOLLOW-UP WAS CONDUCTED, AND THE PATIENT'S RIGHT KNEE JOINT MOBILITY WAS GOOD. 317 DAYS AFTER SURGERY, THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE JOINT. THE RIGHT KNEE JOINT WAS PUNCTURED AND FLUID WAS DRAWN FOR EXAMINATION, INDICATING STREPTOCOCCAL INFECTION. THE PATIENT'S IMAGING EXAMINATION SHOWED THE FORMATION OF A TRANSLUCENT BAND AROUND THE PROSTHESIS, WHICH IS CONSISTENT WITH THE SIGN OF LOOSENING CAUSED BY PROSTHESIS INFECTION. AFTER ADMISSION, THE PATIENT COMPLETED RELEVANT EXAMINATIONS, UNDERWENT JOINT CAVITY PUNCTURE AND FLUID EXTRACTION FOR BACTERIAL CULTURE AND IDENTIFICATION, AND IDENTIFIED THE PATHOGENIC BACTERIA. 334 DAYS AFTER SURGERY, THE PATIENT WAS ADMITTED FOR SURGERY DUE TO P

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25058902 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. THE SUTURE BROKE ON THE FIRST USE. THE PATIENT UNDERWENT SURGERY DUE TO A THORACIC SPINE FRACTURE, DURING WHICH HEMOSTATIC GAUZE WAS USED. DISCHARGE AFTER 6 DAYS. AFTER DISCHARGE, POOR BLOOD SUGAR CONTROL AND POOR NUTRITIONAL STATUS LED TO POOR WOUND HEALING. THE PATIENT WAS READMITTED ON THE EIGHTH DAY AFTER SURGERY. AFTER ADMISSION, COMPLETE PATHOGEN EXAMINATION INDICATES A HIGH POSSIBILITY OF INCISION INFECTION. AFTER ADMISSION, SYMPTOMATIC TREATMENT WAS GIVEN WITH ANTI INFECTION AND NUTRITIONAL SUPPORT. 16 DAYS AFTER THE FIRST SURGERY, ON (B)(6) /2026 ANOTHER SURGERY, A POSTERIOR THORACIC RESECTION DEBRIDEMENT WAS PERFORMED. THE PATIENT CONTINUED TO RECEIVE SYMPTOMATIC TREATMENT WITH ANTI-INFECTION AND NUTRITIONAL SUPPORT AFTER SURGERY (VANCOMYCIN+AZTREONAM, NEGATIVE PRESSURE DRAINAGE DEVICE). THE INFECTION INDICATORS TEND TO IMPROVE. THE PATIENT WAS DISCHARGED 53 DAYS AFTER THE SECOND SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 24857376 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR DISCECTOMY, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT ACTIVELY COMPLETED RELEVANT EXAMINATIONS AFTER ADMISSION AND UNDERWENT SURGERY AFTER RULING OUT SURGICAL CONTRAINDICATIONS. THE DOCTOR USED ABSORBABLE HEMOSTATIC GAUZE DURING THE SURGERY, AND THE SURGERY WENT SMOOTHLY. AFTER THE SURGERY, ANTI-INFLAMMATORY TREATMENT (100ML OF 0.9% SODIUM CHLORIDE INJECTION+INTRAVENOUS INFUSION OF CEFAZOLIN SODIUM 4+72G BID), PAIN RELIEF, SWELLING REDUCTION, AND STOMACH PROTECTION WERE GIVEN. THE PATIENT'S SKIN WAS DELICATE, AND THE WOUND HEALING WAS POOR AFTER SURGERY. THERE WAS FAT LIQUEFACTION AT THE LOWER END OF THE INCISION. RE EXAMINATION OF BLOOD ROUTINE+FULL CYCLE C-RP (WHOLE BLOOD): RED BLOOD CELL COUNT 3.62 10 ^ 12/L , HEMOGLOBIN 109.00G/L ; SERUM ALBUMIN MEASUREMENT (SERUM (VENOUS BLOOD COLLECTION): ALBUMIN 36.6G/L . ON THE 17TH DAY AFTER SURGERY, THE PATIENT'S SKIN WAS DELICATE AND THE WOUND HEALING WAS POOR. THERE WAS FAT LIQUEFACTION AT THE LOWER END OF THE INCISION. THE PATIENT UNDERWENT LUMBAR DEBRIDEMENT AND NEGATIVE PRESSURE DRAINAGE AGA

  Patient problems: Fluid Discharge; Impaired Healing; Insufficient Information; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24835628 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOSCOPIC RADICAL RESECTION FOR LUNG CANCER PROCEDURE ON (B)(6) /2026 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY WITH A HISTORY OF OPEN CHEST SURGERY, SEVERE THORACIC ADHESIONS, AND BLEEDING FROM THE WOUND WAS STOPPED USING HEMOSTATIC GAUZE. AFTER THE SURGERY WAS COMPLETED AND A DRAINAGE TUBE WAS PLACED, THE BLEEDING POINT OF THE INCISION WAS SEEN, AND ELECTROCOAGULATION WAS USED TO STOP THE BLEEDING. AT THIS TIME, A SMALL AMOUNT OF HEMOSTATIC FIBERS STUCK ON THE INCISION CAUGHT FIRE, WHICH MELTED THE DRAINAGE TUBE AND IMMEDIATELY RINSE AND EXTINGUISH WITH STERILIZED WATER. THE FIRE BURNED PART OF THE DRAINAGE TUBE, BUT NO TRACES OF SKIN BURNS WERE FOUND IN THE PATIENT. THE INCISION WAS CLOSED AFTER THE ENDOSCOPIC RE-EXPLORATION OF THE CHEST CAVITY WAS NORMAL. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24638569 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED LUMBAR POSTERIOR DISCECTOMY, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT HAD COMPLEX UNDERLYING DISEASES SUCH AS ADVANCED AGE, POLYCYSTIC KIDNEY DISEASE, RENAL ANEMIA, RENAL INSUFFICIENCY, HYPERTENSION, PARKINSON'S SYNDROME, POOR GENERAL CONDITION, POOR HYGIENE HABITS, AND POOR COMPLIANCE. AFTER ADMISSION, RELEVANT EXAMINATIONS WERE COMPLETED, SURGICAL CONTRAINDICATIONS WERE RULED OUT, AND SURGERY WAS PERFORMED. THE DOCTOR USED ABSORBABLE HEMOSTATIC FLUID GELATIN AND ABSORBABLE HEMOSTATIC GAUZE DURING THE SURGERY. THE SURGERY WENT SMOOTHLY, WITH MINIMAL DRAINAGE AND EXTUBATION. THE POSTOPERATIVE RECOVERY WAS GOOD, AND SYMPTOMS IMPROVED COMPARED TO BEFORE SURGERY. GUIDANCE WAS GIVEN TO USE BRACES TO PROTECT THE PATIENT FROM GETTING OUT OF BED AND GRADUALLY EXERCISE THE FUNCTIONS OF THE FOUR LIMBS. POSTOPERATIVE IMAGING EXAMINATION SHOWED GOOD INTERNAL FIXATION AND FIXATION IN PLACE. ON THE 81ST DAY AFTER SURGERY, IT WAS FOUND THAT THE WOUND HAD POOR HEALING. UNDER THE GUIDANCE OF COLOR DOPPLER ULTRASOUND, PERCUTANEOUS P

  Patient problems: Impaired Healing; Inflammation

  MAUDE report 24503725 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION, LAMINECTOMY, AND LAMINOPLASTY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE, WHICH WAS PERFORMED FOR LUMBAR SPINAL CANAL STENOSIS AT THE WARDS/ICU, THE DOCTOR WAS CALLED DUE TO THE PATIENT¿S LABOR PAINS AND BLEEDING WAS CONFIRMED. ON THE MORNING OF THE 14TH, A HEMATOMA ABOUT THE SIZE OF A FIST WAS FOUND, AND NUMBNESS IN THE PATIENT¿S LEG WAS ALSO CONFIRMED. AFTER DISCUSSING WITH THE PATIENT AND THEIR FAMILY IN THE AFTERNOON, A REOPERATION WAS PERFORMED. AFTER MEETING ON THE MORNING OF THE 18TH, THE PATIENT IS CURRENTLY DOING WELL. ALTHOUGH THE CASUAL RELATIONSHIP WITH THE PRODUCT IS UNKNOWN, THE HOSPITAL STATED THAT THEY HAVE BEEN USING AVITENE WITH ALMOST NO SUCH ISSUES, AND THEREFORE THEY WILL NO LONGER USE THE PRODUCT MOVING FORWARD. THE PRODUCT WAS USED ON THE INTERVERTEBRAL DISC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Numbness; Pain

  MAUDE report 23697877 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC AND LUMBAR SPINE SURGERY AND DEBRIDEMENT AND DRAINAGE PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO THORACOLUMBAR VERTEBRAE. DURING THE SURGERY, ANTIBIOTICS, ARTIFICIAL BONE, HEMOSTATIC FLUID GELATIN, AND HEMOSTATIC GAUZE WERE USED, AND THE INSTRUMENTS WERE USED SMOOTHLY. THE PATIENT WAS DISCHARGED. 50 DAYS AFTER SURGERY, THE PATIENT DEVELOPED WOUND INFECTION AND WAS READMITTED TO THE HOSPITAL. THE WOUND WAS CLEANED AND WASHED, AND SURGERY WAS PERFORMED. CURRENTLY DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Post Operative Wound Infection

  MAUDE report 23692662 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. AFTER SURGERY, WHEN THE SALES REP MET WITH THE SURGEON, HE SAID THAT HE FELT LIKE THERE WERE MORE HEMATOMAS SINCE SWITCHING FROM AVITENE TO ABSORBABLE HEMOSTAT, AND THAT HE HAS PERFORMED HEMATOMA REMOVAL SURGERY. IT WAS UNKNOWN THE ACTUAL DATES OR NUMBER OF SURGERIES, BUT IT SEEMS HE HAS PERFORMED MULTIPLE SURGERIES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma

  MAUDE report 23294252 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, A HEMATOMA WAS FORMED. HEMATOMA REMOVAL SURGERY WAS PERFORMED. THE DOCTOR COMMENTED THAT HE FELT LIKE THERE WERE MORE HEMATOMAS SINCE THE CHANGE FROM AVITENE TO ABSORBABLE HEMOSTAT WHEN THE SALES REP MET WITH THE DOCTOR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma

  MAUDE report 23279507 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL CANCER PROCEDURE ON AN UNKNOWN AND A ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY AND THE DEVICE WAS USED. THE PATIENT HAD A FEVER ON THE DAY AFTER SURGERY. ULTRASOUND EXAMINATION REVEALED PELVIC EFFUSION. SUBSEQUENTLY, ANTIBIOTICS AND DRAINAGE WERE ADMINISTERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Hypervolemia

  MAUDE report 22900487 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR OPEN REDUCTION, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION FOR LUMBAR SPINE FRACTURES PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025 AND AN ABSORBABLE HEMOSTAT WAS USED. ABSORBABLE HEMOSTATIC GAUZE WAS USED FOR LOCAL HEMOSTASIS, AND FLUID GELATIN WAS USED FOR LOCAL HEMOSTASIS DURING THE OUTPATIENT FOLLOW-UP ONE MONTH AFTER SURGERY, THE SUPERVISING DOCTOR FOUND THAT THE WOUND ON THE PATIENT'S WAIST AND BACK HAD NOT HEALED PROPERLY. UPON FURTHER INVESTIGATION OF THE PATIENT'S MEDICAL HISTORY, IT WAS FOUND THAT THE PATIENT HAD UNDERGONE WOUND DRESSING CHANGES AT HOME AFTER DISCHARGE, WHICH MAY HAVE BEEN DUE TO IMPROPER PROCEDURES. ADDITIONALLY, THE PATIENT HAS A CONSTITUTION THAT IS PRONE TO REJECTION REACTIONS, AND THE WOUND CONDITION CANNOT RULE OUT THE POSSIBILITY OF ABSORBABLE HEMOSTATIC GAUZE, FLUID GELATIN REJECTION REACTION, AND INFECTION. IT IS RECOMMENDED THAT THE PATIENT BE HOSPITALIZED FOR TREATMENT. THE PATIENT WAS READMITTED ON THE 36TH DAY AFTER SURGERY. ON THE 39TH DAY AFTER SURGERY, THE PATIENT UNDERWENT LUMBAR SPINE WOUND DEBRIDEMENT, PERFUSION IRRIGATION AND DRAINAGE SURGERY. VISIBLE CHANGES IN THE

  Patient problems: Hypersensitivity/Allergic reaction; Impaired Healing; Unspecified Infection

  MAUDE report 22738782 ↗
• MalfunctionAug 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, A SCRUB NURSE FOUND THAT THERE HAD BEEN A FOREIGN MATTER WHEN THE PACKAGE WAS OPENED TO USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699517 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR POSTERIOR APPROACH RESECTION, SPINAL CANAL DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2025 AND AN ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY FOR LUMBAR SPONDYLOLISTHESIS. DURING THE SURGERY, ABSORBABLE HEMOSTATIC GAUZE AND ABSORBABLE HEMOSTATIC FLUID GELATIN WERE USED FOR INTRAOPERATIVE HEMOSTASIS; 13 DAYS AFTER SURGERY, THE PATIENT DEVELOPED WOUND INFECTION AND SUSTAINED HIGH FEVER; ON (B)(6) 2025 TWO WOUND DEBRIDEMENT, PERFUSION, IRRIGATION, AND DRAINAGE SURGERIES WERE PERFORMED. CURRENTLY, THE PATIENT'S CONDITION IS STABLE, WITH NO FEVER OR OBVIOUS EXUDATION FROM THE WOUND. VSD NEGATIVE PRESSURE SUCTION IS CURRENTLY BEING PERFORMED ON THE WOUND. AT PRESENT, WOUND DEBRIDEMENT WITH NEGATIVE PRESSURE SUCTION AND EXTERNAL USE OF SENSITIVE ANTIBIOTICS FOR TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Post Operative Wound Infection

  MAUDE report 22669482 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY, SYNOVECTOMY, MICROFRACTURE, RIGHT TIBIAL OSTEOTOMY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO RIGHT KNEE OSTEOARTHRITIS, RIGHT KNEE VARUS DEFORMITY, AND RIGHT KNEE VILLONODULAR SYNOVITIS. THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED. AFTER DISCHARGE, THE PATIENT UNDERWENT SURGERY IN ANOTHER HOSPITAL AND AFTER THE SURGERY, THE WOUND WAS FOUND TO BE POORLY HEALED, THEN ANOTHER SURGERY WAS PERFORMED. FOR FURTHER DIAGNOSIS AND TREATMENT, THE PATIENT CAME TO OUR HOSPITAL AGAIN 49 DAYS AFTER THE FIRST OPERATION, ON (B)(6) 2025 AND UNDERWENT ELECTIVE DEBRIDEMENT AND SUTURE SURGERY THE NEXT DAY. ANTI-INFECTION TREATMENT AND WAS DISCHARGED AFTER THE WOUND HEALED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 22394605 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR SPINE PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY FOR LUMBAR DISC HERNIATION. FLUID GELATIN AND HEMOSTATIC GAUZE WERE USED DURING THE SURGERY. THE SURGERY WENT SMOOTHLY AND THE PATIENT WAS DISCHARGED. THE PATIENT DEVELOPED FEVER AFTER THE SURGERY AND CAME TO THE HOSPITAL FOR FURTHER TREATMENT 12 DAYS LATER. CONSIDERING POSTOPERATIVE INFECTION OF THE LUMBAR SPINE, THE PATIENT WAS GIVEN ANTIBIOTICS FOR ACTIVE TREATMENT. THE PATIENT'S SYMPTOMS IMPROVED WITHOUT ANY SPECIAL DISCOMFORT AND WAS DISCHARGED. 273 DAYS AFTER THE SURGERY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AGAIN FOR POSTOPERATIVE PAIN IN THE LUMBAR SPINE AND UNDERWENT SURGERY ON (B)(6) 2025; A REMOVAL OF SPINAL INTERNAL FIXATION DEVICE+WOUND PERFUSION AND SOFT TISSUE INCISION DRAINAGE SURGERY. THE PATIENT WAS DISCHARGED AFTER THE WOUND HEALED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Inflammation; Pain

  MAUDE report 22292623 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL AND THORACIC SPINAL CANAL EXPANSION DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO CERVICAL AND THORACIC SPINAL STENOSIS. DURING THE SURGERY, FLUID GELATIN WAS USED FOR HEMOSTASIS. AFTER THE SURGERY, INFECTION WAS PREVENTED AND DRESSINGS WERE CHANGED REGULARLY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 11 DAYS LATER AND CONTINUED TREATMENT IN THE REHABILITATION DEPARTMENT OF OUR HOSPITAL AFTER DISCHARGE. AFTER 19 DAYS, INCISION INFECTION, EXUDATION, AND DEEP ABSCESS FORMATION WERE FOUND. BACTERIAL CULTURE INDICATED ENTEROBACTER CLOACAE INFECTION. THE PATIENT UNDERWENT SURGERY AGAIN 23 DAYS AFTER THE SURGERY, DEBRIDEMENT AND DRAINAGE ON (B)(6) 2025. ANTI-INFECTION TREATMENT WAS ACTIVELY CARRIED OUT AFTER THE SURGERY, AND THE PATIENT IS CURRENTLY IN STABLE CONDITION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Fluid Discharge; Unspecified Infection

  MAUDE report 22292461 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR SPINE FRACTURE OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR LUMBAR FRACTURE. AFTER ADMISSION, RELEVANT EXAMINATIONS WERE COMPLETED AND SURGERY WAS PERFORMED. HEMOSTATIC GAUZE AND FLUID GELATIN WERE USED DURING THE SURGERY. THE SURGERY WAS SUCCESSFUL. THE PATIENT WAS IN THE HOSPITAL FOR 13 DAYS AND WAS DISCHARGED AFTER THE WOUND HEALED WELL. 225 DAYS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR "SKIN SINUS FORMATION IN THE LUMBAR AND BACK." PREVIOUSLY, THE PATIENT HAD A LUMP IN THE LOWER BACK 6 MONTHS AGO, WHICH WAS PAINFUL WHEN PRESSED. THEN THE LUMP RUPTURED AND LIGHT-YELLOW LIQUID FLOWED INTERMITTENTLY. THE PATIENT HAD NO SYSTEMIC FEVER, CHILLS, OR COUGH. THE PATIENT WENT TO THE LOCAL HOSPITAL FOR WOUND CLEANING AND ANTI-INFECTION TREATMENT. AFTER ADMISSION, THE PATIENT UNDERWENT WOUND DRESSING CHANGE, ANTI-INFECTION, AND COLOR DOPPLER ULTRASOUND-GUIDED FLUID DRAINAGE TREATMENT OF THE LUMBAR AND BACK EFFUSION. 248 DAYS AFTER THE FIRST OPERATION, THE PATIENT WAS HOSPITALIZED AGAIN FOR SURGERY ON (B)(6) 2025D DEBRIDEMENT AND INTERN

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 22289413 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DISCECTOMY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. ABSORBABLE HEMOSTATIC FLUID GELATIN WAS USED DURING THE SURGERY, AND SYMPTOMATIC TREATMENT SUCH AS ANTI-INFLAMMATORY THERAPY WAS GIVEN AFTER THE SURGERY. STANDARDIZE DRESSING CHANGES OUTSIDE THE HOSPITAL AND REMOVE STITCHES ON TIME. THE PATIENT HAS A HISTORY OF HYPERTENSION AND A LONG-TERM SMOKING HISTORY. RECURRENT LOWER BACK PAIN ACCOMPANIED BY RADIATING PAIN AND DISCOMFORT IN THE LEFT LOWER LIMB. ON THE 40TH DAY AFTER SURGERY, THE PATIENT UNDERWENT A FOLLOW-UP LUMBAR MRI IN THE OUTPATIENT DEPARTMENT, WHICH SHOWED BONE DESTRUCTION IN THE LUMBAR VERTEBRAE 4-5, ABNORMAL SIGNALS IN THE ENDPLATE AND INTERVERTEBRAL SPACE, AND SUSPECTED INFECTIOUS LESIONS. THE PATIENT WAS FURTHER ADMITTED AND GIVEN SYMPTOMATIC TREATMENT SUCH AS ANTIBIOTICS FOR ANTI INFECTION, ANTI-INFLAMMATORY AND PAIN RELIEF. THE INFECTION INDICATORS AND CLINICAL SYMPTOMS WERE CLOSELY MONITORED, AND THE PATIENT'S SYMPTOMS IMPROVED. CURRENTLY, THE PATIENT IS UNDERGOING INPATIENT ANTI INFECTION TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Bone Notching; Discomfort; Impaired Healing; Pain; Unspecified Infection

  MAUDE report 22198342 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR DISCECTOMY, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION ASSISTED BY S8 NAVIGATION PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS ADMITTED WITH "LUMBAR DISC HERNIATION" AND UNDERWENT ROUTINE PREOPERATIVE EXAMINATIONS TO RULE OUT SURGICAL CONTRAINDICATIONS. THE PATIENT UNDERWENT SURGERY AND USED HEMOSTATIC GAUZE TO STOP BLEEDING DURING THE OPERATION. PROVIDE POSTOPERATIVE NUTRITIONAL SUPPORT AND ANTI INFECTIVE TREATMENT TO THE PATIENT, AND REMOVE THE WOUND DRAINAGE TUBE WHEN THE DRAINAGE VOLUME DECREASES. ON THE 21ST DAY AFTER SURGERY, THE PATIENT FOUND A LARGE AMOUNT OF EXUDATE FROM THE WOUND DRESSING DURING DRESSING CHANGE. WHEN THE DRESSING WAS REMOVED, A MODERATE AMOUNT OF BROWN LIQUID COULD BE SEEN OOZING FROM THE WOUND, INDICATING POOR WOUND HEALING. THE PATIENT WAS READMITTED ON THE 21ST DAY AFTER SURGERY AND UNDERWENT ROUTINE DRESSING CHANGES DAILY. THE EXUDATE WAS COLLECTED FOR BACTERIAL CULTURE AND PCR TESTING. BASED ON THE CORRESPONDING RESULTS, THE CLINICAL PHARMACY DEPARTMENT WAS CONSULTED TO GUIDE ANTI INFECTIVE TREATMENT. ADJUST THE TREATMENT PLA

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 22107565 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE JOINT REPLACEMENT PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO RIGHT KNEE OSTEOARTHRITIS. ABSORBABLE HEMOSTATIC GAUZE WAS USED DURING THE SURGERY AND THE PATIENT WAS DISCHARGED SMOOTHLY. TRANSFER TO A LOCAL HOSPITAL TO CONTINUE SYMPTOMATIC TREATMENT SUCH AS PAIN RELIEF, SWELLING REDUCTION, AND INFECTION PREVENTION. ON (B)(6), THERE WAS POOR HEALING OF THE WOUND DUE TO EXUDATION, ACCOMPANIED BY PAIN. ON (B)(6) 2025, DUE TO POOR HEALING IN THE DEPARTMENT AFTER RIGHT KNEE REPLACEMENT SURGERY, THE PATIENT WAS ADMITTED TO THE HOSPITAL. AND PERFORM DEBRIDEMENT AND KNEE JOINT PAD REPLACEMENT SURGERY ON (B)(6) 2025. CURRENTLY UNDERGOING TREATMENT IN THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing; Pain

  MAUDE report 22038392 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR SPINE POSTERIOR ROBOT ASSISTED DECOMPRESSION, BONE GRAFTING, FUSION, INTERNAL FIXATION, AND PRP IMPLANTATION PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025, AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025, DUE TO LUMBAR DISC HERNIATION. ABSORBABLE HEMOSTATIC GAUZE WERE USED DURING THE SURGERY, AND THE SURGERY WENT SMOOTHLY WITH GOOD POSTOPERATIVE RECOVERY. THE PATIENT WAS DISCHARGED FOR REHABILITATION AND EXERCISE TREATMENT; AFTER THE PATIENT WAS DISCHARGED, THE PATIENT SUDDENLY DEVELOPED A HIGH FEVER. THE WOUND WAS REGULARLY CLEANED AND DRESSING CHANGED. DURING THE DRESSING CHANGE, IT WAS FOUND THAT THERE WAS A WAVE SENSATION IN THE WOUND AREA. CONTINUING THE WOUND CLEANING AND DRESSING CHANGE, THE PATIENT WENT TO THE LOCAL HOSPITAL FOR FURTHER TREATMENT AND UNDERWENT WOUND FLUID EXTRACTION SURGERY. HOWEVER, THE WAVE SENSATION STILL EXISTED IN THE WOUND. THEREFORE, THE PATIENT CONTACTED OUR DEPARTMENT AND WAS READMITTED FOR FURTHER TREATMENT ON (B)(6) 2025 DUE TO WOUND INFECTION. AFTER COMPLETING RELEVANT EXAMINATIONS, SURGICAL CONTRAINDICATIONS WERE RULED OUT AND DEBRIDEMENT AND IRRIGATION SURGERY

  Patient problems: Fever; Impaired Healing; Insufficient Information; Post Operative Wound Infection

  MAUDE report 21929699 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL ATLANTOAXIAL REDUCTION, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY IN OUR HOSPITAL DUE TO ATLANTOAXIAL DISLOCATION. HEMOSTATIC GAUZE AND FLUID GELATIN WERE USED TO STOP BLEEDING DURING THE SURGERY, AND THE SURGERY WENT SMOOTHLY. THE PATIENT'S CONDITION WAS STABLE AFTER THE SURGERY AND CONTINUED REHABILITATION TREATMENT IN A LOCAL HOSPITAL AFTER DISCHARGE. 22 DAYS AFTER SURGERY, THE PATIENT FOUND PRESSURE SORES ON THE UPPER PART OF THE INCISION AND POOR HEALING AND THEN CAME TO THE HOSPITAL FOR EXAMINATION THREE DAYS LATER AND WAS ADMITTED TO THE HOSPITAL DUE TO POOR HEALING OF THE CERVICAL SPINE POSTOPERATIVE INCISION. AFTER ADMISSION, THE INCISION SECRETION CULTURE SHOWED INFECTION WITH DRUG-RESISTANT STAPHYLOCOCCUS EPIDERMIDIS. VANCOMYCIN HYDROCHLORIDE WAS GIVEN FOR ANTI-INFECTION TREATMENT, AND DRESSING CHANGES WERE STRENGTHENED UNTIL THE INCISION HEALED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Pressure Sore/Ulcer; Unspecified Infection

  MAUDE report 21882932 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR SPINE PROCEDURE ON (B)(6) 2024, AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO A BURST FRACTURE OF THE LUMBAR VERTEBRA 1. HEMOSTATIC GAUZE WAS IMPLANTED DURING THE SURGERY TO STOP BLEEDING. THE PATIENT WAS DISCHARGED WITH GOOD RESULTS. 50 DAYS LATER, THE PATIENT HAD POOR WOUND HEALING AND WAS ADMITTED TO THE HOSPITAL. SURGERY WAS PERFORMED 2 DAYS LATER. ANTI-INFECTION AND DRESSING WERE GIVEN AFTER THE SURGERY. THE WOUND HEALED WELL AND WAS DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing

  MAUDE report 21778237 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LESION CLEARANCE, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE ON THE THORACOLUMBAR SPINE ON (B)(6) 2024, UNDER GENERAL ANESTHESIA AND ABSORBABLE HEMOSTAT WAS USED. AFTER ADMISSION, RELEVANT EXAMINATIONS WERE COMPLETED, AND SURGICAL CONTRAINDICATIONS WERE RULED OUT. SURGERY WAS PERFORMED. SYMPTOMATIC TREATMENT WAS GIVEN AFTER SURGERY, AND ROUTINE PATHOLOGICAL EXAMINATION OF THE THORACIC VERTEBRAE SHOWED LARGE AREAS OF NECROSIS AND DEAD BONE WITH GRANULOMA FORMATION, EXCLUDING BONE TUBERCULOSIS. PLEASE CONSIDER THE CLINICAL SITUATION. GENETIC TESTING SHOWS BRUCELLOSIS. THE PATIENT'S WOUND HEALED WELL AFTER SURGERY, AND THE WOUND WAS DRY WITHOUT EXUDATION. AFTER APPROVAL BY THE SUPERIOR PHYSICIAN, THE DISCHARGE PROCEDURES WERE PROCESSED. THE PATIENT WAS INSTRUCTED TO BE PROTECTED WITH BRACES FOR 3 MONTHS AFTER DISCHARGE, AND THE WOUND DRESSING SHOULD BE CHANGED 3-5 DAYS LATER. THE DRESSING SHOULD BE REMOVED ACCORDING TO THE WOUND HEALING CONDITION AT 2 WEEKS AFTER SURGERY. AFTER DISCHARGE, THE PATIENT SHOULD TAKE ORAL ANTI TUBERCULOSIS AND ANTI BRUCELLOSIS TREATMENTS SUCH AS RIFAMPICIN, ISONIAZID, DOXYCYCLINE, ETHAMBUTOL, PYR

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 21777880 ↗