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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 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
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 324 324
Insufficient Information 60 60
Appropriate Term/Code Not Available 28 28
Product Quality Problem 18 18
Material Disintegration 15 15
Fluid/Blood Leak 14 14
Material Puncture/Hole 12 12
Material Split, Cut or Torn 11 11
Degraded 11 11
Material Integrity Problem 11 11
Patient Device Interaction Problem 11 11
Hole In Material 7 7
Nonstandard Device 7 7
Device Appears to Trigger Rejection 7 7
Microbial Contamination of Device 6 6
Break 5 5
Material Rupture 5 5
Compatibility Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Device Operates Differently Than Expected 4 4
Lack of Effect 4 4
Device Markings/Labelling Problem 4 4
Gel Leak 3 3
Defective Device 3 3
Material Separation 3 3
Poor Quality Image 3 3
Contamination /Decontamination Problem 3 3
Patient-Device Incompatibility 3 3
Fracture 2 2
Migration or Expulsion of Device 2 2
No Apparent Adverse Event 2 2
Device Contamination With Biological Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Unsealed Device Packaging 2 2
Torn Material 2 2
Shelf Life Exceeded 2 2
Naturally Worn 2 2
Material Erosion 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1
Loose or Intermittent Connection 1 1
Biocompatibility 1 1
Device Expiration Issue 1 1
Mechanical Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Misassembly by Users 1 1
Expulsion 1 1
Off-Label Use 1 1
Leak/Splash 1 1
Physical Resistance/Sticking 1 1
Detachment Of Device Component 1 1
Component Missing 1 1
Melted 1 1
Device Dislodged or Dislocated 1 1
Delivered as Unsterile Product 1 1
Failure to Seal 1 1
Material Twisted/Bent 1 1
Expiration Date Error 1 1
Difficult to Remove 1 1
Failure To Adhere Or Bond 1 1
Contamination 1 1
Defective Component 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cerebrospinal Fluid Leakage 226 226
Unspecified Infection 74 74
Meningitis 64 64
Injury 53 53
Headache 37 37
Post Operative Wound Infection 25 25
Fever 24 24
Bacterial Infection 24 24
No Known Impact Or Consequence To Patient 21 21
No Clinical Signs, Symptoms or Conditions 19 19
Hydrocephalus 18 18
Inflammation 17 17
Failure of Implant 16 16
Fistula 16 16
Pain 15 15
Adhesion(s) 13 13
Abscess 12 12
Hematoma 12 12
Hypersensitivity/Allergic reaction 10 10
Swelling/ Edema 10 10
Insufficient Information 9 9
Hemorrhage/Bleeding 9 9
Foreign Body Reaction 9 9
Wound Dehiscence 8 8
Edema 8 8
No Consequences Or Impact To Patient 8 8
Seizures 7 7
Death 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Tissue Injury 7 7
Not Applicable 7 7
Purulent Discharge 6 6
Vomiting 6 6
Swelling 5 5
No Code Available 5 5
No Information 4 4
Cerebral Edema 4 4
Numbness 4 4
Sepsis 4 4
Seroma 4 4
Dizziness 4 4
Muscle Weakness 4 4
Cyst(s) 4 4
Emotional Changes 3 3
Local Reaction 3 3
Visual Impairment 3 3
No Patient Involvement 3 3
Patient Problem/Medical Problem 3 3
Cancer 3 3
Discomfort 3 3
Muscle Spasm(s) 3 3
Impaired Healing 3 3
Reaction 2 2
Fungal Infection 2 2
Complaint, Ill-Defined 2 2
Hernia 2 2
Stenosis 2 2
Ambulation Difficulties 2 2
Unspecified Nervous System Problem 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Weakness 2 2
Paralysis 2 2
Paresis 2 2
Rash 2 2
Nausea 2 2
Low Blood Pressure/ Hypotension 2 2
Laceration(s) 2 2
Anaphylactic Shock 2 2
Bradycardia 2 2
Hemorrhage, Subdural 2 2
Hyperplasia 1 1
High Blood Pressure/ Hypertension 1 1
Intracranial Hemorrhage 1 1
Hemorrhage, Subarachnoid 1 1
Hearing Impairment 1 1
Granuloma 1 1
Hair Loss 1 1
Calcium Deposits/Calcification 1 1
Infarction, Cerebral 1 1
Abrasion 1 1
Failure to Anastomose 1 1
Aneurysm 1 1
Facial Nerve Paralysis 1 1
Fall 1 1
Fatigue 1 1
Necrosis 1 1
Neurological Deficit/Dysfunction 1 1
Muscular Rigidity 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1
Scar Tissue 1 1
Burning Sensation 1 1
Tingling 1 1
Dysphasia 1 1
Brain Injury 1 1
Convulsion, Tonic 1 1
Visual Disturbances 1 1
Therapeutic Effects, Unexpected 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix, Inc. II Feb-24-2022
2 Medtronic Neurosurgery II Jul-20-2023
3 Synthes (USA) Products LLC II Oct-11-2018
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