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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 ELEKTROMEDIZINISCHE GERAETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 380 380
2018 337 337
2019 498 498
2020 549 549
2021 498 498

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 1315 1315
Adverse Event Without Identified Device or Use Problem 337 337
Loss of Osseointegration 325 325
Patient Device Interaction Problem 114 114
Insufficient Information 48 48
Biocompatibility 22 22
Expulsion 21 21
Failure to Osseointegrate 19 19
Patient-Device Incompatibility 17 17
Inadequacy of Device Shape and/or Size 11 11
Extrusion 10 10
Device Appears to Trigger Rejection 7 7
Osseointegration Problem 6 6
Device Dislodged or Dislocated 4 4
Use of Device Problem 4 4
Migration 3 3
Misassembly During Maintenance/Repair 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Battery Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Thermal Decomposition of Device 2 2
Migration or Expulsion of Device 2 2
No Apparent Adverse Event 2 2
Device Operates Differently Than Expected 2 2
Missing Value Reason 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Unintended Movement 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Component Missing 1 1
Device Issue 1 1
Detachment of Device or Device Component 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 408 408
No Code Available 354 354
Host-Tissue Reaction 218 218
Pain 210 210
Patient Problem/Medical Problem 208 208
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 173 173
Bacterial Infection 158 158
No Clinical Signs, Symptoms or Conditions 73 73
Impaired Healing 65 65
Hearing Impairment 51 51
No Information 47 47
Skin Inflammation/ Irritation 43 43
Tissue Breakdown 43 43
Skin Irritation 37 37
Discomfort 36 36
Swelling 35 35
Implant Pain 33 33
Inadequate Osseointegration 32 32
Skin Infection 31 31
Inflammation 30 30
Cellulitis 30 30
Insufficient Information 29 29
Headache 28 28
Head Injury 27 27
Scar Tissue 25 25
Purulent Discharge 22 22
Fluid Discharge 17 17
Post Operative Wound Infection 13 13
Necrosis 13 13
Necrosis Of Flap Tissue 13 13
Wound Dehiscence 12 12
Skin Disorders 11 11
Foreign Body Reaction 10 10
Swelling/ Edema 8 8
No Consequences Or Impact To Patient 7 7
Hematoma 7 7
Skin Inflammation 6 6
No Known Impact Or Consequence To Patient 5 5
Hemorrhage/Bleeding 5 5
Failure of Implant 5 5
Abscess 5 5
Erythema 4 4
Irritation 4 4
Staphylococcus Aureus 4 4
Discharge 4 4
Ulcer 3 3
Pressure Sores 3 3
Skin Erosion 3 3
Dizziness 3 3
Missing Value Reason 3 3
Erosion 3 3
Fall 2 2
Edema 2 2
Granuloma 2 2
Hearing Loss 2 2
Osteomyelitis 2 2
Increased Sensitivity 2 2
Solid Tumour 2 2
No Patient Involvement 2 2
Injury 2 2
Scar Excision 2 2
Burning Sensation 2 2
Therapeutic Response, Decreased 2 2
Scarring 1 1
Seroma 1 1
Meningitis 1 1
Rash 1 1
Tinnitus 1 1
Tissue Damage 1 1
Fistula 1 1
Deafness 1 1
Autoimmune Disorder 1 1
Ossification 1 1

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