Durepair® 62105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169063860), received between Jan 3, 2018 and Sep 4, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 13, 2023Open, Classified

   Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.

   Z-2207-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2023Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON JUNE 9, 2023, THE PATIENT HAD ACUTE HEADACHE OVERNIGHT. THEY WERE STARTED ON DILAUDID PCA. THE PATIENT IMPROVED BUT WAS STILL THERE. IT WAS DULL AND LOCATED FRONTAL. THEIR CT SCAN DID DEMONSTRATE PNEUMOCEPHALUS. ON (B)(6) 2023, THERE WERE NO ACUTE EVENTS OVERNIGHT. THE PATIENT REPORTED THEIR WAS IMPROVED. REPEAT CTH REPORTS DECREASING PNEUMOCEPHALUS. IT WAS NOTED THAT THEIR MEDICATIONS WERE CHANGED WHICH MADE A SIGNIFICANT DIFFERENCE. THE INCISION WAS INTACT AND DRY. ON (B)(6) 2023, A CT SCAN WAS PERFORMED. THE VENTRICLES WERE NORMAL IN SIZE AND CONFIGURATION. PNEUMOCEPHALUS WAS RESOLVED. A FLUID COLLECTION WAS IDENTIFIED AT THE BRAIN BASE IN THE OCCIPITAL CRANIECTOMY SITE. A RETENTION CYST WAS NOTED IN THE RIGHT MAXILLARY SINUS. A SMALL RETENTION CYST WAS NOTED IN THE SPHENOID SINUS. ON (B)(6) 2023, THE PATIENT EXPERIENCED VERY HIGH FEVERS (UP TO 107F). THEY WERE TAKEN TO THE OPERATING ROOM AND A CSF LEAK REPAIR. IT WAS FOUND THAT THE GRAFT HAD BEEN PARTIALLY BROKEN DOWN, AND THERE WAS A VERY LARGE PSEUDO MENINGOCELE. THE PATCH WAS REMOVED AND REPLACED. THEIR TEMPERATURE IMMEDIATELY REDUCED. SAMPLES OF THE CSF DEM ONSTRATED INFECTIO

  Patient problems: Cyst(s); Fever; Headache; Meningitis; Pain

  MAUDE report 17676594 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. DUREPAIR IMPLANTED (B)(6) 2023 AND WAS NOT EXPLANTED. DAY OF SURGERY WBC 12.2 AND CONTINUED TO TREND UP. (B)(6) 2023 ANCEF ORDERED. (B)(6) 2023 WBC 15.6, FEBRILE MAX TEMP. 101.7. (B)(6) 2023 WBC 26.5, FEBRILE MAX TEMP. 100.6. (B)(6) 2023 WBC 44.1, FEBRILE MAX TEMP. 100.2. (B)(6) 2023 WBC 25.6 FEBRILE MAX TEMP. 101.3- CHEST XRAY HAZY BIBASILAR INFILTRATES , VANCOMYCIN ORDERED WBCS CAME DOWN. CONTINUED WITH BIBASILAR PNA. DISCHARGED TO SNF.

  Patient problems: Unspecified Infection

  MAUDE report 17435171 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO WAS BROUGHT INTO THE OR TO EXPLORE A POSSIBLE CSF LEAK AT THE GRAFT SITE THAT WAS IMPLANTED ON (B)(6) 2022. ONCE THE DOCTOR OBSERVED THIS THEY REPORTED THIS EVENT TO THE REPRESENTATIVE. THE DOCTOR DID NOT THINK THE GRAFT SHOULD HAVE LOOKED LIKE THAT AFTER THIS SHORT OF TIME WITH THE PATIENT. HE SENT CULTURES OF THE SITE TO THE CYTOLOGY TO BE EXAMINED. THE RESULTS WERE NOT BACK AT THE TIME OF FILING. THE DURAREPAIR WAS REMOVED AND REPLACED WITH A DIFFERENT PRODUCT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16130883 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP). IT WAS REPORTED THAT THE EVIDENCE OF INFECTION PRESENTED ITSELF TO THE PATIENT SO SHE SCHEDULED AN APPOINTMENT TO HAVE THE BONE FLAP REMOVED AND START A BROAD-SPECTRUM OF ANTIBIOTICS. THE PATIENT'S SYMPTOMS INCLUDED RIGHT ARM WEAKNESS AND THE PATIENT THOUGHT SHE MAY HAVE HAD A MILD SEIZURE. THE PATIENT IS CURRENTLY RECOVERING FROM THE INFECTION. THERE WERE NO EXTERNAL FACTORS THAT WERE RECORDED AS A POTENTIAL INFLUENCE.

  Patient problems: Bacterial Infection; Complaint, Ill-Defined; Muscle Weakness/Atrophy; Seizures

  MAUDE report 7280101 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MEDWATCH REPORT THAT A (B)(6) PATIENT UNDERWENT GLIOMA SURGERY. SUBSEQUENTLY, THE CSF THAT WAS DRAWN FROM THE PATIENT WAS LEFT OUT ON THE COUNTER FOR AN EXTENDED PERIOD OF TIME IN THE PATIENT'S ROOM. WHEN CULTURED, THE CSF TESTED POSITIVE FOR BIPOLARIS.

  Patient problems: Fungal Infection

  MAUDE report 7161292 ↗