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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hearing aid, bone conduction
Regulation Description Hearing Aid.
Product CodeLXB
Regulation Number 874.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 5
MED-EL
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM DEMANT HOLDING A/S
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 820 820
2016 695 695
2017 380 380
2018 337 337
2019 497 497
2020 331 331

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 2142 2142
Loss of Osseointegration 493 493
Adverse Event Without Identified Device or Use Problem 158 158
Insufficient Information 122 122
Failure to Osseointegrate 34 34
Magnet 31 31
Biocompatibility 20 20
Patient Device Interaction Problem 18 18
Patient-Device Incompatibility 17 17
Extrusion 17 17
Osseointegration Problem 10 10
Expulsion 6 6
Device Dislodged or Dislocated 4 4
Use of Device Problem 4 4
Missing Value Reason 4 4
Improper or Incorrect Procedure or Method 4 4
Migration 3 3
Device Operates Differently Than Expected 3 3
Migration or Expulsion of Device 3 3
Material Integrity Problem 2 2
Battery Problem 2 2
Battery 2 2
Thermal Decomposition of Device 2 2
Loose or Intermittent Connection 2 2
Device Appears to Trigger Rejection 1 1
Device Inoperable 1 1
Contamination 1 1
Defective Component 1 1
Unintended Movement 1 1
Receiver Stimulator Unit 1 1
Flange 1 1
Screw 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment of Device or Device Component 1 1
Component Missing 1 1
Device Issue 1 1
Device Handling Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 667 667
Bacterial Infection 453 453
Unspecified Infection 448 448
No Information 371 371
Patient Problem/Medical Problem 357 357
Pain 299 299
Host-Tissue Reaction 235 235
Hearing Impairment 104 104
Swelling 75 75
Head Injury 63 63
Inflammation 58 58
Skin Irritation 47 47
Impaired Healing 32 32
Discomfort 30 30
Tissue Breakdown 30 30
Headache 25 25
Cellulitis 24 24
Necrosis Of Flap Tissue 24 24
Irritation 18 18
Scar Tissue 16 16
Deafness 15 15
Wound Dehiscence 13 13
Hematoma 12 12
Purulent Discharge 12 12
Foreign Body Reaction 11 11
Post Operative Wound Infection 10 10
Discharge 10 10
No Consequences Or Impact To Patient 8 8
Necrosis 8 8
Seroma 7 7
Skin Inflammation 7 7
Abscess 7 7
Skin Erosion 6 6
Fluid Discharge 5 5
No Known Impact Or Consequence To Patient 5 5
Staphylococcus Aureus 5 5
Erosion 4 4
Erythema 4 4
Hearing Loss 3 3
Ulcer 3 3
Pressure Sores 3 3
Scar Excision 3 3
Dizziness 3 3
Inadequate Osseointegration 3 3
Edema 3 3
Missing Value Reason 3 3
Fistula 2 2
No Patient Involvement 2 2
Therapeutic Response, Decreased 2 2
Injury 2 2
Failure of Implant 2 2
Hypersensitivity/Allergic reaction 1 1
Device Overstimulation of Tissue 1 1
Rash 1 1
Cerebrospinal Fluid Leakage 1 1
Cyst(s) 1 1
Numbness 1 1
Meningitis 1 1
Reaction 1 1
Tinnitus 1 1
Tissue Damage 1 1
Blood Loss 1 1
Device Embedded In Tissue or Plaque 1 1
Bone Fracture(s) 1 1
Death 1 1
Ossification 1 1
Scarring 1 1
Hemorrhage, Subarachnoid 1 1
Nausea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cochlear Americas Inc. II Jan-24-2020
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