DurepairRecalls & reported problems across all models

We found 6 models of Durepair by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2018 and Apr 25, 2024 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

1 FDA recall record name at least one of these models by its device 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. 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

Durepair 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. 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 · names 6 of these models · Recall details · FDA record ↗

Most reported Durepair problems

Durepair models

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

• Durepair® 62100

  DURA SUBSTITUTE
  1 recall6 reports
• Durepair® 62105

  DURA SUBSTITUTE
  1 recall5 reports
• Durepair® 62110

  DURA SUBSTITUTE
  1 recall3 reports
• Durepair® 62106

  DURA SUBSTITUTE
  1 recall1 report
• Durepair® 62111

  DURA SUBSTITUTE
  1 recall1 report
• Durepair® 62158

  DURA SUBSTITUTE
  1 recall0 reports

Recent Durepair adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED IN MARCH OF LAST YEAR. THEY SAID THAT THERE WAS A LEAK THAT HAD SINCE BEEN CONTROLLED AND HAD BEEN IN CONTACT WITH THEIR DOCTOR.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19182140 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT A PATIENT DID WELL FOR SOME TIME AFTER A TETHERED CORD RELEASE WITH EXPANSILE PATCH DURAPLASTY AND INTRAOPERATIVE ULTRASOUND BUT DEVELOPED A DELAYED PSEUDOMENINGOCELE FOR WHICH THE SITE PERFORMED A VENTRICULOPERITONEAL (VP) SHUNT EXPLORATION WHICH WAS FOUND TO BE FUNCTIONAL, AS WELL AS A LUMBAR WOUND EXPLORATION, AND CEREBROSPINAL FLUID (CSF) LEAK REPAIR WITH REVISION DURAPLASTY DUE TO A CONCERN FOR AN ISSUE WITH THE DURAL SUBSTITUTE PATCH WHICH WAS CONFIRMED WITH A COMPLEX PLASTIC SURGERY CLOSURE. PATIENT DID EXTREMELY WELL FROM THIS OPERATION, AND HAD BEEN AT HOME. VISITING THE SITE TODAY WAS THE PATIENT'S FIRST TIME LEAVING THEIR HOUSE SINCE SURGERY. OVERALL THEY WERE DOING QUITE WELL. PREOPERATIVELY, THEY WERE EXPERIENCING SIGNIFICANT HEADACHES WHICH HAD SINCE COMPLETELY RESOLVED. PATIENT WAS ALSO EXPERIENCING SIGNIFICANT BACK PAIN WITH TENDERNESS TO TOUCH OF THEIR BACK DUE TO A LARGE PSEUDOMENINGOCELE THAT WAS PRESENT BUT CONTAINED WITHIN THE SKIN. THIS WAS ALSO IMPROVED SIGNIFICANTLY SINCE SURGERY, AND THEY WERE ESSENTIALLY PAIN-FREE. THE PATIENT DID NOT HAVE ANY RADICULAR PAIN, AN

  Patient problems: Cerebrospinal Fluid Leakage; Discomfort; Headache; Pain

  MAUDE report 18969199 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT A PATIENT WITH HISTORY OF MYELOMENINGOCELE AND TETHERED SPINAL CORD WHO UNDERWENT A TETHERED CORD RELEASE WITH PATCH DURAPLASTY USING INTRAOPERATIVE ULTRASOUND AND OPERATING MICROSCOPE ALMOST A YEAR AGO, WHICH WAS COMPLICATED BY A SYMPTOMATIC PSEUDOMENINGOCELE REQUIRING RE-EXPLORATION AND CEREBROSPINAL FLUID (CSF) LEAK REPAIR, AS WELL AS RECURRENT CSF LEAK REQUIRING RE-EXPLORATION, VENTRICULOPERITONEAL SHUNT PLACEMENT AND COMPLEX PLASTIC SURGERY CLOSURE, WHOSE COURSE WAS ALSO COMPLICATED BY DEHISCENCE OF THE SHUNT INCISION WHICH REQUIRED SHUNT REMOVAL. MOST RECENTLY, THE PATIENT HAD ANOTHER DELAYED RE-ACCUMULATION OF A PSEUDOMENINGOCELE WHICH CAUSED BACK AND LEG PAIN, FOR WHICH THE SITE ADMITTED THEM TO THE HOSPITAL AND PERFORMED A LUMBAR WOUND TAP, EXTERNAL VENTRICULAR DRAIN (EVD) PLACEMENT, CONFIRMED CULTURES NEGATIVE, AND PLACED A LEFT VENTRICULOPERITONEAL SHUNT. AFTER THESE PROCEDURES, THE PATIENT WAS AMBULATORY WITHOUT BACK OR LEG PAIN. THEY WERE EVENTUALLY DISCHARGED IN FAIRLY GOOD CONDITION AND HAD BEEN AT HOME. SINCE THEN THEIR BACK PAIN HAS REOCCURRED, AND THEY WERE ALSO EXPERIE

  Patient problems: Cerebrospinal Fluid Leakage; Cramp(s) /Muscle Spasm(s); Impaired Healing; Pain

  MAUDE report 18968451 ↗
• InjuryFeb 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE, AND THE PATIENT SUSTAINED PERSONAL INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18738621 ↗
• 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 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT DEVICE REMOVAL RESOLVED THE EVENT.

  Patient problems: Headache; Pain; Unspecified Infection

  MAUDE report 17550992 ↗
• 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 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ADVERSE REACTION. RIGHT L2, L3, L4 LAMINOTOMIES PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, PATIENT EXPERIENCED A SURGICAL WOUND DEHISCENCE AND INFECTION. OUTPATIENT CULTURES REVEALED MSSA. ON (B)(6)2022 PATIENT RETURNED TO THE OR FOR WOUND DEBRIDEMENT, DURAPLASTY AND CLOSURE OF WOUND DEHISCENCE. PATIENT STARTED ON IV CEFTRIAXONE FOR 6 WEEKS FROM (B)(6) 2022. A DUREPAIR WAS IMPLANTED.

  Patient problems: Local Reaction

  MAUDE report 17288909 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A UNKNOWN DURAREPAIR. IT WAS REPORTED THAT A PATIENT HAD AN ADVERSE REACTION. RIGHT POSTERIOR FOSSA CRANIOTOMY PERFORMED ON (B)(6) 2023 - MEDTRONIC DUREPAIR DEVICE, 62110, LOT 2207017. ON (B)(6) 2023 PATIENT DEVELOPED HEADACHES, INCREASED FATIGUE, FEVER AND WOUND DRAINAGE - COPIOUS PURULENT YELLOW DRAINAGE. URGENT MRI CONDUCTED ON (B)(6) 2023 AND DEMONSTRATED DEEP WOUND INFECTION. PATIENT BROUGHT EMERGENTLY TO THE OPERATING ROOM ON (B)(6) 2023 FOR IRRIGATION, DEBRIDEMENT, CRANIECTOMY AND WOUND CLOSURE. LUMBAR CSF DRAIN ALSO PLACED. THE PRIOR DURAPLASTY REPAIR APPEARED MACERATED AND 3 FOCAL AREAS OF CSF EGRESS UNDER PRESSURE WERE IDENTIFIED. REPEAT SURGERY CONDUCTED ON (B)(6) 2023 AFTER THE LUMBAR DRAIN HAD BEEN REMOVED AS PATIENT DEVELOPED CSF LEAK AGAIN. PERFORMED EXTERNAL VENTRICULOSTOMY AND DRAIN PLACEMENT TO PROVIDE CSF DIVERSION. CSF SENT FOR CULTURE, WHICH WAS POSITIVE FOR MRSA. ON (B)(6) 2023 THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO PLACE A VENTRICULOPERITONEAL SHUNT FOR POSTINFECTIOUS HYDROCEPHALUS. ON (B)(6) 2023 IT WAS IDENTIFIED THAT THE PATIENT MET CRITERIA FOR AN ORGAN SPACE SSI.

  Patient problems: Local Reaction

  MAUDE report 17288801 ↗
• OtherJun 22, 2023Nonstandard Device

  DUREPAIR DURA REGENERATION MATRIX - ALL LOT NUMBERS - URGENT MEDICAL DEVICE RECALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192266 ↗
• 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 ↗
• InjuryApr 15, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A DUREPAIR. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS PERFORMING A CHIARI MALFORMATION PROCEDURE ON (B)(6) 2022. THE HCP USED A 2X2 INCH DUREPAIR. THE PATIENT DEVELOPED A PSEUDOMENINGOCELE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2022 AND THE HCP STATED THAT THE DUREPAIR HAD DISINTEGRATED. DURING THE PROCEDURE ON APRIL 8TH THE HCP USED DUREPAIR AND IT KEPT TEARING AND THE SUTURE WAS PULLING THROUGH.

  Patient problems: Hydrocephalus

  MAUDE report 14120427 ↗
• InjuryApr 15, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A DUREPAIR. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS PERFORMING A CHIARI MALFORMATION PROCEDURE ON (B)(6) 2022. THE HCP USED A 2X2 INCH DUREPAIR. THE PATIENT DEVELOPED A PSEUDOMENINGOCELE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2022 AND THE HCP STATED THAT THE DUREPAIR HAD DISINTEGRATED. DURING THE PROCEDURE ON (B)(6) 2022 THE HCP USED DUREPAIR AND IT KEPT TEARING AND THE SUTURE WAS PULLING THROUGH.

  Patient problems: Hydrocephalus

  MAUDE report 14120422 ↗
• InjurySep 27, 2019Material Disintegration; Fluid/Blood Leak; Material Disintegration; Fluid/Blood Leak

  IT WAS REPORTED THAT IN LATE 2018, THE PATIENT WAS DIAGNOSED WITH WEAKNESS IN HER LEFT ARM; SHE WAS UNABLE TO LIFT HER ARM ABOVE 40 DEGREES PROXIMALLY. A CERVICAL MRI SHOWED A LARGE CYST AT THE C4-05 LEVEL. INITIALLY, DOCTORS RECOMMENDED AND THE PATIENT UNDERWENT CONSERVATIVE TREATMENT TO STRENGTHEN HER LEFT ARM, BUT THAT WASN'T SUCCESSFUL. THE PATIENT UNDERWENT A LAMINOPLASTY WITH RESECTION OF THE CYST AND DURAPLASTY ON (B)(6) 2019. DURING THIS SURGERY, THE PATIENT'S PHYSICIAN UTILIZED THE REPORTED DEVICE. HOWEVER, THIS PRODUCT DID NOT PERFORM AS EXPECTED AND AS IT SHOULD HAVE. AS A DIRECT AND PROXIMATE RESULT OF, THE PATIENT SUFFERED A CEREBROSPINAL FLUID LEAK. THE PATIENT SOON SUFFERED FROM HEADACHES, NAUSEA, VOMITING, AND GAIT DEFICIT. SHE WAS ADMITTED TO THE EMERGENCY ROOM AT THE HOSPITAL, WHERE HER DOCTORS QUICKLY FOUND THAT THE DURAPLASTY HAD FAILED WHERE THE DURAL PATCH HAD ALMOST DISINTEGRATED. THE PATIENT UNDERWENT A REPAIR OF CERVICAL DURAPLASTY ON (B)(6) 2019. SINCE THAT TIME, SHE IS UNABLE TO WALK WITHOUT THE ASSISTANCE OF THE WALKER, AND SHE HAS SUFFERED FROM CONTINUAL BACK, SHOULDER, AND NECK PAIN. SHE HAS ALSO COMPLAINED OF ARM AND LEG NUMBNESS, TINGLING, AND LEG SP

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9128568 ↗
• 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 ↗

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