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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dura substitute
Product CodeGXQ
Regulation Number 882.5910
Device Class 2


Premarket Reviews
ManufacturerDecision
ACERA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
LEMAITRE VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROSURGERY
  SUBSTANTIALLY EQUIVALENT 1
NURAMI MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 18 18
2015 62 62
2016 58 58
2017 57 57
2018 94 94
2019 63 63
2020 114 114
2021 76 76
2022 59 59
2023 110 110
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 372 372
Insufficient Information 82 82
Appropriate Term/Code Not Available 45 45
Fluid/Blood Leak 21 21
Product Quality Problem 19 19
Material Disintegration 18 18
Device Operates Differently Than Expected 18 18
Material Integrity Problem 12 12
Material Puncture/Hole 12 12
Material Split, Cut or Torn 11 11
Degraded 11 11
Leak/Splash 11 11
Patient Device Interaction Problem 11 11
Hole In Material 8 8
Break 8 8
Nonstandard Device 7 7
Device Appears to Trigger Rejection 7 7
Improper or Incorrect Procedure or Method 7 7
Torn Material 6 6
Microbial Contamination of Device 6 6
Material Separation 6 6
Separation Failure 5 5
Material Rupture 5 5
Device Markings/Labelling Problem 5 5
Compatibility Problem 5 5
Patient-Device Incompatibility 5 5
Failure To Adhere Or Bond 4 4
Lack of Effect 4 4
Shelf Life Exceeded 4 4
Device Expiration Issue 4 4
Defective Device 3 3
Gel Leak 3 3
Poor Quality Image 3 3
Contamination /Decontamination Problem 3 3
No Apparent Adverse Event 2 2
Use of Device Problem 2 2
Component Missing 2 2
Contamination 2 2
Defective Component 2 2
Difficult to Remove 2 2
Fracture 2 2
Migration or Expulsion of Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Sticking 2 2
Device Contamination With Biological Material 2 2
Unsealed Device Packaging 2 2
Naturally Worn 2 2
Material Erosion 2 2
Biocompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Device remains implanted 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Repair 1 1
Off-Label Use 1 1
Misassembly by Users 1 1
Expulsion 1 1
Chemical Spillage 1 1
Device Contamination with Chemical or Other Material 1 1
Fitting Problem 1 1
Physical Resistance/Sticking 1 1
Detachment Of Device Component 1 1
Material Twisted/Bent 1 1
Expiration Date Error 1 1
Material Discolored 1 1
Device Inoperable 1 1
Melted 1 1
Device Dislodged or Dislocated 1 1
Delivered as Unsterile Product 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cerebrospinal Fluid Leakage 253 253
Unspecified Infection 99 99
Meningitis 72 72
Injury 56 56
Headache 50 50
Fever 36 36
No Known Impact Or Consequence To Patient 34 34
Bacterial Infection 30 30
Post Operative Wound Infection 26 26
Inflammation 25 25
Hydrocephalus 22 22
No Code Available 20 20
Pain 20 20
No Clinical Signs, Symptoms or Conditions 19 19
Failure of Implant 16 16
Fistula 16 16
Hematoma 16 16
Adhesion(s) 15 15
Abscess 13 13
No Consequences Or Impact To Patient 12 12
No Information 11 11
Death 11 11
Hypersensitivity/Allergic reaction 11 11
Wound Dehiscence 10 10
Swelling/ Edema 10 10
Insufficient Information 9 9
Hemorrhage/Bleeding 9 9
Foreign Body Reaction 9 9
Nausea 9 9
Vomiting 9 9
Swelling 8 8
Purulent Discharge 8 8
Edema 8 8
Seizures 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Tissue Injury 7 7
Not Applicable 7 7
Reaction 6 6
Cancer 5 5
Cerebral Edema 4 4
No Patient Involvement 4 4
Numbness 4 4
Complaint, Ill-Defined 4 4
Impaired Healing 4 4
Dizziness 4 4
Sepsis 4 4
Seroma 4 4
Neurological Deficit/Dysfunction 4 4
Muscle Weakness 4 4
Cyst(s) 4 4
Emotional Changes 3 3
Failure to Anastomose 3 3
Paralysis 3 3
Muscle Spasm(s) 3 3
Local Reaction 3 3
Scar Tissue 3 3
Weakness 3 3
Visual Impairment 3 3
Discomfort 3 3
Fungal Infection 3 3
Ambulation Difficulties 3 3
Patient Problem/Medical Problem 3 3
Fluid Discharge 2 2
Unspecified Nervous System Problem 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Cognitive Changes 2 2
Confusion/ Disorientation 2 2
Loss of consciousness 2 2
Blurred Vision 2 2
Hernia 2 2
Stenosis 2 2
Therapeutic Response, Decreased 2 2
Visual Disturbances 2 2
Rash 2 2
Fatigue 2 2
Low Blood Pressure/ Hypotension 2 2
Laceration(s) 2 2
Memory Loss/Impairment 2 2
Paresis 2 2
Anaphylactic Shock 2 2
Bradycardia 2 2
Hemorrhage, Subdural 2 2
Hyperplasia 1 1
High Blood Pressure/ Hypertension 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Hemorrhage, Subarachnoid 1 1
Hearing Impairment 1 1
Fungus 1 1
Granuloma 1 1
Hair Loss 1 1
Calcium Deposits/Calcification 1 1
Infarction, Cerebral 1 1
Facial Nerve Paralysis 1 1
Fall 1 1
Aneurysm 1 1
Arthritis 1 1
Autoimmune Reaction 1 1
Syncope 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix, Inc. II Feb-24-2022
2 Integra LifeSciences Corp II Mar-11-2010
3 Integra LifeSciences Corp. II Nov-24-2010
4 Integra LifeSciences Corporation II May-10-2013
5 Medtronic Neurosurgery II Jul-20-2023
6 Synovis Surgical Innovations, Inc. II Nov-18-2013
7 Synthes (USA) Products LLC II Oct-11-2018
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