TPLC - Total Product Life Cycle

• Device: stimulator, bone growth, non-invasive
• Product Code: LOF
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
4	1	9	2	3	7	7	8	5	10	8	3	2	7	5	2

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	31	31
2016	48	48
2017	55	55
2018	36	36
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	490	490
Insufficient Information	330	330
Adverse Event Without Identified Device or Use Problem	303	303
Off-Label Use	28	28
Appropriate Term/Code Not Available	18	18
Biocompatibility	13	13
Overheating of Device	8	8
Device Operates Differently Than Expected	6	6
Inappropriate/Inadequate Shock/Stimulation	5	5
Patient Device Interaction Problem	5	5
Temperature Problem	4	4
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	2	2
No Apparent Adverse Event	2	2
Unexpected Therapeutic Results	2	2
Component Incompatible	2	2
Device-Device Incompatibility	2	2
Device Dislodged or Dislocated	1	1
Inadequate Lighting	1	1
Power Conditioning Problem	1	1
Battery Problem	1	1
Fluid/Blood Leak	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	1	1
Nonstandard Device	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Sparking	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	431	431
Skin Inflammation/ Irritation	227	227
Rash	104	104
Skin Irritation	92	92
Itching Sensation	88	88
Blister	64	64
Burning Sensation	53	53
Hypersensitivity/Allergic reaction	40	40
Burn(s)	39	39
Swelling/ Edema	31	31
No Code Available	31	31
Unspecified Infection	27	27
Wheal(s)	26	26
Swelling	23	23
Cramp(s) /Muscle Spasm(s)	19	19
Headache	18	18
Shock	15	15
Numbness	14	14
Discomfort	12	12
Bruise/Contusion	11	11
Reaction	11	11
Erythema	10	10
Inflammation	7	7
Nausea	7	7
Ossification	6	6
Lead(s), Burn(s) From	6	6
Irritability	5	5
Skin Inflammation	5	5
Skin Burning Sensation	5	5
Muscle Spasm(s)	5	5
High Blood Pressure/ Hypertension	5	5
Skin Discoloration	5	5
Tissue Damage	5	5
Abrasion	4	4
Post Traumatic Wound Infection	4	4
Pressure Sores	4	4
Electric Shock	4	4
Neck Pain	3	3
Neck Stiffness	3	3
Skin Tears	3	3
Shock from Patient Lead(s)	3	3
No Known Impact Or Consequence To Patient	3	3
Partial thickness (Second Degree) Burn	3	3
Hair Loss	3	3
Urticaria	3	3
Dizziness	3	3
Palpitations	3	3
Unspecified Heart Problem	3	3
Bacterial Infection	3	3
Chest Pain	3	3
Irritation	3	3
Fatigue	3	3
Complaint, Ill-Defined	3	3
Vertigo	2	2
Vomiting	2	2
Weakness	2	2
Necrosis	2	2
Staphylococcus Aureus	2	2
Scarring	2	2
Hemorrhage/Bleeding	2	2
Diarrhea	2	2
Failure of Implant	2	2
Incontinence	2	2
Cellulitis	2	2
Skin Infection	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Ambulation Difficulties	2	2
Contact Dermatitis	2	2
Nodule	2	2
Fungal Infection	2	2
Superficial (First Degree) Burn	2	2
Patient Problem/Medical Problem	2	2
Vascular System (Circulation), Impaired	1	1
Sleep Dysfunction	1	1
No Information	1	1
Cancer	1	1
Lymphoma	1	1
Constipation	1	1
Convulsion/Seizure	1	1
Sensitivity of Teeth	1	1
Shaking/Tremors	1	1
No Consequences Or Impact To Patient	1	1
Myalgia	1	1
Ulcer	1	1
Drug Resistant Bacterial Infection	1	1
Reaction to Medicinal Component of Device	1	1
Increased Sensitivity	1	1
Vitamin Deficiency	1	1
Malunion of Bone	1	1
Calcium Deposits/Calcification	1	1
Cyst(s)	1	1
Death	1	1
Dehydration	1	1
Wound Dehiscence	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1
Abscess	1	1
Adhesion(s)	1	1
Arthritis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bioventus, LLC	II	Jan-09-2021