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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
LEMAITRE VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
NURAMI MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 63 63
2020 114 114
2021 76 76
2022 59 59
2023 110 110
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 259 259
Insufficient Information 47 47
Product Quality Problem 18 18
Fluid/Blood Leak 12 12
Material Disintegration 11 11
Material Puncture/Hole 11 11
Patient Device Interaction Problem 11 11
Material Split, Cut or Torn 11 11
Material Integrity Problem 9 9
Degraded 8 8
Nonstandard Device 7 7
Device Appears to Trigger Rejection 7 7
Appropriate Term/Code Not Available 7 7
Compatibility Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Device Markings/Labelling Problem 4 4
Material Rupture 4 4
Break 4 4
Lack of Effect 4 4
Gel Leak 3 3
Material Separation 3 3
Material Erosion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Microbial Contamination of Device 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Naturally Worn 2 2
No Apparent Adverse Event 2 2
Physical Resistance/Sticking 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Failure to Seal 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Component Missing 1 1
Expiration Date Error 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Material Twisted/Bent 1 1
Misassembly by Users 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Difficult to Remove 1 1
Delivered as Unsterile Product 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cerebrospinal Fluid Leakage 174 174
Unspecified Infection 55 55
Meningitis 36 36
Headache 29 29
Injury 25 25
Fever 23 23
No Clinical Signs, Symptoms or Conditions 19 19
Bacterial Infection 18 18
Inflammation 17 17
Failure of Implant 14 14
Hypersensitivity/Allergic reaction 12 12
Fistula 12 12
Pain 12 12
Hydrocephalus 12 12
Post Operative Wound Infection 11 11
No Known Impact Or Consequence To Patient 11 11
Swelling/ Edema 11 11
Adhesion(s) 10 10
Abscess 9 9
Hematoma 9 9
Insufficient Information 9 9
Hemorrhage/Bleeding 8 8
Foreign Body Reaction 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Tissue Injury 7 7
Wound Dehiscence 6 6
Swelling 5 5
No Consequences Or Impact To Patient 5 5
Numbness 4 4
Vomiting 4 4
Seizures 4 4
Sepsis 4 4
Cyst(s) 4 4
Edema 4 4
Cerebral Edema 4 4
Impaired Healing 3 3
Patient Problem/Medical Problem 3 3
Cancer 3 3
Emotional Changes 3 3
Muscle Spasm(s) 3 3
Muscle Weakness 3 3
Seroma 3 3
Local Reaction 3 3
Discomfort 3 3
Rash 2 2
Stenosis 2 2
Hernia 2 2
Paralysis 2 2
Nausea 2 2
Laceration(s) 2 2
Low Blood Pressure/ Hypotension 2 2
Purulent Discharge 2 2
Bradycardia 2 2
Anaphylactic Shock 2 2
Unspecified Nervous System Problem 2 2
Ambulation Difficulties 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Skin Inflammation/ Irritation 1 1
Solid Tumour 1 1
Drug Resistant Bacterial Infection 1 1
Convulsion/Seizure 1 1
Movement Disorder 1 1
Ischemia Stroke 1 1
No Patient Involvement 1 1
Fluid Discharge 1 1
Sleep Dysfunction 1 1
No Code Available 1 1
Thrombosis/Thrombus 1 1
Erectile Dysfunction 1 1
Abrasion 1 1
Calcium Deposits/Calcification 1 1
Death 1 1
Erythema 1 1
Facial Nerve Paralysis 1 1
Fall 1 1
Fatigue 1 1
Granuloma 1 1
Hair Loss 1 1
Hearing Impairment 1 1
Intracranial Hemorrhage 1 1
Hyperplasia 1 1
High Blood Pressure/ Hypertension 1 1
Muscular Rigidity 1 1
Necrosis 1 1
Paresis 1 1
Scar Tissue 1 1
Weakness 1 1
Burning Sensation 1 1
Tingling 1 1
Dizziness 1 1
Dysphasia 1 1
Therapeutic Effects, Unexpected 1 1
Urinary Retention 1 1
Visual Disturbances 1 1
Subclinical Infection 1 1
Brain Injury 1 1
Convulsion, Tonic 1 1
Urticaria 1 1
Anxiety 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix, Inc. II Feb-24-2022
2 Medtronic Neurosurgery II Jul-20-2023
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