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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, implanted
Regulation Description Hearing Aid.
Product CodeMAH
Regulation Number 874.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COCHLEAR AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
OTICON MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 613 613
2018 628 628
2019 634 634
2020 692 692
2021 706 706

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 1753 1753
Loss of Osseointegration 493 493
Adverse Event Without Identified Device or Use Problem 442 442
Failure to Osseointegrate 328 328
Patient Device Interaction Problem 171 171
Insufficient Information 53 53
Loosening of Implant Not Related to Bone-Ingrowth 21 21
Osseointegration Problem 17 17
Patient-Device Incompatibility 12 12
Biocompatibility 8 8
Inadequacy of Device Shape and/or Size 8 8
Device Appears to Trigger Rejection 3 3
Device Displays Incorrect Message 3 3
Thermal Decomposition of Device 2 2
No Apparent Adverse Event 2 2
Extrusion 2 2
Compatibility Problem 1 1
No Flow 1 1
Migration 1 1
High impedance 1 1
Improper or Incorrect Procedure or Method 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 743 743
No Code Available 455 455
Host-Tissue Reaction 390 390
Inadequate Osseointegration 369 369
Bacterial Infection 335 335
Patient Problem/Medical Problem 275 275
Pain 220 220
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 144 144
Impaired Healing 110 110
Head Injury 103 103
Inflammation 69 69
Skin Infection 69 69
Fluid Discharge 61 61
Skin Irritation 55 55
Swelling 49 49
Post Operative Wound Infection 45 45
No Clinical Signs, Symptoms or Conditions 44 44
Insufficient Information 44 44
Cellulitis 44 44
Hearing Impairment 42 42
No Information 36 36
Skin Inflammation/ Irritation 35 35
Scar Tissue 33 33
Purulent Discharge 25 25
Discomfort 22 22
Discharge 21 21
Swelling/ Edema 21 21
Skin Inflammation 20 20
Foreign Body Reaction 20 20
Staphylococcus Aureus 16 16
Irritation 13 13
Wound Dehiscence 11 11
Headache 9 9
Implant Pain 9 9
Skin Disorders 8 8
No Consequences Or Impact To Patient 8 8
Erythema 8 8
Abscess 7 7
Failure of Implant 6 6
Necrosis Of Flap Tissue 5 5
Hemorrhage/Bleeding 4 4
Hypersensitivity/Allergic reaction 3 3
Hematoma 3 3
Erosion 3 3
Skin Erosion 3 3
Tissue Breakdown 3 3
No Patient Involvement 2 2
Ulcer 2 2
Reaction to Medicinal Component of Device 2 2
Missing Value Reason 2 2
Necrosis 2 2
Fall 2 2
Deafness 2 2
Granuloma 2 2
Rash 1 1
Scarring 1 1
Infiltration into Tissue 1 1
Itching Sensation 1 1
Nausea 1 1
Drug Resistant Bacterial Infection 1 1
Burning Sensation 1 1
Dizziness 1 1
No Known Impact Or Consequence To Patient 1 1

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