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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, bone growth, non-invasive
Product CodeLOF
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
8 3 2 7 5 2

MDR Year MDR Reports MDR Events
2019 54 54
2020 142 142
2021 246 246
2022 158 158
2023 149 149
2024 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 431 431
Insufficient Information 303 303
Adverse Event Without Identified Device or Use Problem 251 251
Off-Label Use 27 27
Appropriate Term/Code Not Available 12 12
Overheating of Device 6 6
Patient Device Interaction Problem 5 5
Device-Device Incompatibility 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Unexpected Therapeutic Results 2 2
Component Incompatible 2 2
Fluid/Blood Leak 1 1
Battery Problem 1 1
Use of Device Problem 1 1
Defective Component 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 399 399
Skin Inflammation/ Irritation 227 227
Itching Sensation 74 74
Blister 64 64
Rash 63 63
Skin Irritation 59 59
Burning Sensation 43 43
Swelling/ Edema 31 31
Burn(s) 25 25
Hypersensitivity/Allergic reaction 24 24
Cramp(s) /Muscle Spasm(s) 19 19
Unspecified Infection 18 18
Shock 15 15
Headache 14 14
Swelling 13 13
Numbness 12 12
Bruise/Contusion 11 11
Discomfort 10 10
No Code Available 9 9
Wheal(s) 7 7
Irritability 5 5
Skin Burning Sensation 5 5
Inflammation 5 5
Nausea 4 4
Pressure Sores 4 4
Erythema 3 3
High Blood Pressure/ Hypertension 3 3
Abrasion 3 3
Unspecified Heart Problem 3 3
Post Traumatic Wound Infection 3 3
Urticaria 3 3
Dizziness 3 3
Vertigo 2 2
Fungal Infection 2 2
Skin Tears 2 2
Neck Pain 2 2
Neck Stiffness 2 2
Skin Infection 2 2
Bacterial Infection 2 2
Irritation 2 2
Hemorrhage/Bleeding 2 2
Skin Discoloration 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Contact Dermatitis 2 2
Nodule 2 2
Drug Resistant Bacterial Infection 1 1
Reaction to Medicinal Component of Device 1 1
Thrombus 1 1
Scarring 1 1
Increased Sensitivity 1 1
Necrosis 1 1
Neuropathy 1 1
Muscle Spasm(s) 1 1
Myocardial Infarction 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Adhesion(s) 1 1
Arthritis 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1
Chest Pain 1 1
Diarrhea 1 1
Non specific EKG/ECG Changes 1 1
Increased Sensitivity 1 1
Vitamin Deficiency 1 1
Malunion of Bone 1 1
Constipation 1 1
Convulsion/Seizure 1 1
Ambulation Difficulties 1 1
Electric Shock 1 1
Vascular System (Circulation), Impaired 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Sensitivity of Teeth 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Sore Throat 1 1
Blurred Vision 1 1
Loss of Vision 1 1
Hot Flashes/Flushes 1 1
Tingling 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bioventus, LLC II Jan-09-2021
2 EBI, LLC II Apr-23-2024
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