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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 3
MED-EL
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM DEMANT HOLDING A/S
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 695 695
2017 380 380
2018 337 337
2019 498 498
2020 549 549

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 1615 1615
Loss of Osseointegration 394 394
Adverse Event Without Identified Device or Use Problem 258 258
Insufficient Information 56 56
Patient Device Interaction Problem 34 34
Magnet 31 31
Biocompatibility 20 20
Extrusion 17 17
Failure to Osseointegrate 16 16
Patient-Device Incompatibility 16 16
Expulsion 10 10
Osseointegration Problem 7 7
Use of Device Problem 4 4
Device Dislodged or Dislocated 4 4
Missing Value Reason 4 4
Migration 3 3
Improper or Incorrect Procedure or Method 3 3
Battery Problem 2 2
Battery 2 2
Thermal Decomposition of Device 2 2
Material Integrity Problem 2 2
Device Operates Differently Than Expected 2 2
Migration or Expulsion of Device 2 2
Flange 1 1
Screw 1 1
Labelling, Instructions for Use or Training Problem 1 1
Component Missing 1 1
Device Issue 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Unintended Movement 1 1
Receiver Stimulator Unit 1 1
Loose or Intermittent Connection 1 1
Device Appears to Trigger Rejection 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 517 517
Unspecified Infection 430 430
Patient Problem/Medical Problem 357 357
Pain 258 258
Bacterial Infection 245 245
Host-Tissue Reaction 237 237
No Information 102 102
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 86 86
Hearing Impairment 65 65
Swelling 58 58
Inflammation 44 44
Skin Irritation 43 43
Head Injury 39 39
Tissue Breakdown 30 30
Discomfort 29 29
Cellulitis 28 28
Headache 24 24
Necrosis Of Flap Tissue 20 20
Scar Tissue 15 15
Purulent Discharge 14 14
Irritation 14 14
Skin Inflammation/ Irritation 13 13
Skin Infection 12 12
Wound Dehiscence 12 12
Fluid Discharge 11 11
Foreign Body Reaction 11 11
Impaired Healing 10 10
Post Operative Wound Infection 9 9
Necrosis 9 9
Hematoma 9 9
No Consequences Or Impact To Patient 8 8
Insufficient Information 8 8
Skin Disorders 8 8
Seroma 7 7
Skin Inflammation 7 7
No Clinical Signs, Symptoms or Conditions 7 7
Discharge 6 6
Skin Erosion 6 6
Abscess 6 6
Staphylococcus Aureus 5 5
No Known Impact Or Consequence To Patient 5 5
Erosion 4 4
Implant Pain 4 4
Swelling/ Edema 4 4
Missing Value Reason 3 3
Edema 3 3
Deafness 3 3
Hearing Loss 3 3
Failure of Implant 3 3
Pressure Sores 3 3
Scar Excision 3 3
Ulcer 2 2
Erythema 2 2
Fall 2 2
Granuloma 2 2
Hemorrhage/Bleeding 2 2
Injury 2 2
Dizziness 2 2
Therapeutic Response, Decreased 2 2
No Patient Involvement 2 2
Inadequate Osseointegration 2 2
Device Embedded In Tissue or Plaque 1 1
Tinnitus 1 1
Tissue Damage 1 1
Scarring 1 1
Hemorrhage, Subarachnoid 1 1
Ossification 1 1
Nausea 1 1
Fistula 1 1
Death 1 1
Cyst(s) 1 1
Rash 1 1
Numbness 1 1

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