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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dura substitute
Regulation Description Dura substitute.
Product CodeGXQ
Regulation Number 882.5910
Device Class 2


Premarket Reviews
ManufacturerDecision
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 58 58
2017 57 57
2018 94 94
2019 63 63
2020 114 114
2021 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 181 181
Insufficient Information 47 47
Appropriate Term/Code Not Available 36 36
Product Quality Problem 18 18
Material Disintegration 12 12
Fluid Leak 11 11
Hole In Material 8 8
Material Split, Cut or Torn 8 8
Material Integrity Problem 8 8
Device Operates Differently Than Expected 7 7
Degraded 7 7
Patient Device Interaction Problem 6 6
Device Appears to Trigger Rejection 6 6
Leak/Splash 6 6
Improper or Incorrect Procedure or Method 6 6
Torn Material 5 5
Material Puncture/Hole 5 5
Microbial Contamination of Device 4 4
Compatibility Problem 4 4
Contamination /Decontamination Problem 3 3
Poor Quality Image 3 3
Failure To Adhere Or Bond 3 3
Device Markings/Labelling Problem 3 3
Defective Device 3 3
Patient-Device Incompatibility 3 3
Device Expiration Issue 3 3
Shelf Life Exceeded 2 2
Migration or Expulsion of Device 2 2
Unsealed Device Packaging 2 2
Gel Leak 2 2
Contamination 2 2
Material Rupture 2 2
Device Contamination With Biological Material 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Sticking 1 1
Material Discolored 1 1
Detachment Of Device Component 1 1
Physical Resistance/Sticking 1 1
Component Missing 1 1
No Apparent Adverse Event 1 1
Off-Label Use 1 1
Nonstandard Device 1 1
Use of Device Problem 1 1
Material Separation 1 1
Break 1 1
Melted 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cerebrospinal Fluid Leakage 141 141
Unspecified Infection 66 66
Injury 54 54
Meningitis 47 47
No Known Impact Or Consequence To Patient 27 27
Headache 23 23
Bacterial Infection 17 17
Post Operative Wound Infection 16 16
Inflammation 15 15
Fever 13 13
Fistula 11 11
Pain 9 9
Hydrocephalus 9 9
No Consequences Or Impact To Patient 9 9
No Code Available 8 8
Edema 8 8
Death 8 8
Adhesion(s) 7 7
Seizures 7 7
Not Applicable 7 7
No Information 7 7
Swelling 7 7
Wound Dehiscence 7 7
Abscess 6 6
Failure of Implant 6 6
Purulent Discharge 6 6
Vomiting 5 5
Hematoma 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Muscle Spasm(s) 3 3
Muscle Weakness 3 3
Neurological Deficit/Dysfunction 3 3
Weakness 3 3
Visual Impairment 3 3
Dizziness 3 3
Complaint, Ill-Defined 3 3
No Patient Involvement 3 3
Patient Problem/Medical Problem 3 3
Reaction 2 2
Scar Tissue 2 2
Seroma 2 2
Foreign Body Reaction 2 2
Hemorrhage, Subdural 2 2
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Failure to Anastomose 2 2
Paresis 2 2
Rash 2 2
Hypersensitivity/Allergic reaction 2 2
Cancer 2 2
Ambulation Difficulties 2 2
Hernia 2 2
Numbness 2 2
Fungal Infection 2 2
Neck Pain 1 1
Neck Stiffness 1 1
Nasal Obstruction 1 1
Therapeutic Effects, Unexpected 1 1
Immunodeficiency 1 1
Convulsion, Tonic 1 1
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Convulsion/Seizure 1 1
Cyst(s) 1 1
Fall 1 1
Aneurysm 1 1
Arthritis 1 1
Autoimmune Reaction 1 1
Calcium Deposits/Calcification 1 1
Staphylococcus Aureus 1 1
Neuropathy 1 1
Nausea 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Hemorrhage, Subarachnoid 1 1
Granuloma 1 1
Facial Nerve Paralysis 1 1
Infarction, Cerebral 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Blurred Vision 1 1
Tingling 1 1
Irritability 1 1
Impaired Healing 1 1
Dysphasia 1 1
Stenosis 1 1
Therapeutic Response, Decreased 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Oct-11-2018
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