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	74	74

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	529	529
Insufficient Information	348	348
Adverse Event Without Identified Device or Use Problem	306	306
Off-Label Use	33	33
Appropriate Term/Code Not Available	18	18
Biocompatibility	13	13
Overheating of Device	8	8
Device Operates Differently Than Expected	6	6
Patient Device Interaction Problem	5	5
Inappropriate/Inadequate Shock/Stimulation	5	5
Temperature Problem	4	4
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	2	2
Device-Device Incompatibility	2	2
No Apparent Adverse Event	2	2
Unexpected Therapeutic Results	2	2
Component Incompatible	2	2
Fluid/Blood Leak	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	1	1
Nonstandard Device	1	1
Power Conditioning Problem	1	1
Battery Problem	1	1
Inadequate or Insufficient Training	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Sparking	1	1
Device Dislodged or Dislocated	1	1
Inadequate Lighting	1	1
Measurement System Incompatibility	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	447	447
Skin Inflammation/ Irritation	240	240
Rash	116	116
Itching Sensation	93	93
Skin Irritation	92	92
Blister	67	67
Burning Sensation	53	53
Hypersensitivity/Allergic reaction	43	43
Burn(s)	39	39
Swelling/ Edema	32	32
No Code Available	31	31
Unspecified Infection	27	27
Wheal(s)	26	26
Swelling	23	23
Headache	20	20
Cramp(s) /Muscle Spasm(s)	20	20
Shock	17	17
Numbness	16	16
Discomfort	12	12
Reaction	11	11
Bruise/Contusion	11	11
Erythema	10	10
Nausea	8	8
Inflammation	7	7
Ossification	6	6
Lead(s), Burn(s) From	6	6
Skin Burning Sensation	5	5
Irritability	5	5
Skin Inflammation	5	5
High Blood Pressure/ Hypertension	5	5
Muscle Spasm(s)	5	5
Skin Discoloration	5	5
Tissue Damage	5	5
Fatigue	4	4
Abrasion	4	4
Post Traumatic Wound Infection	4	4
Electric Shock	4	4
Pressure Sores	4	4
Neck Pain	3	3
Neck Stiffness	3	3
Complaint, Ill-Defined	3	3
Skin Tears	3	3
Palpitations	3	3
No Known Impact Or Consequence To Patient	3	3
Partial thickness (Second Degree) Burn	3	3
Shock from Patient Lead(s)	3	3
Unspecified Heart Problem	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Bacterial Infection	3	3
Chest Pain	3	3
Irritation	3	3
Hair Loss	3	3
Urticaria	3	3
Dizziness	3	3
Vomiting	2	2
Weakness	2	2
Vertigo	2	2
Staphylococcus Aureus	2	2
Scarring	2	2
Tachycardia	2	2
Necrosis	2	2
Failure of Implant	2	2
Incontinence	2	2
Hemorrhage/Bleeding	2	2
Cellulitis	2	2
Diarrhea	2	2
Arrhythmia	2	2
Ambulation Difficulties	2	2
Insufficient Information	2	2
Convulsion/Seizure	2	2
Skin Infection	2	2
Contact Dermatitis	2	2
Nodule	2	2
Superficial (First Degree) Burn	2	2
Patient Problem/Medical Problem	2	2
Fungal Infection	2	2
Sensitivity of Teeth	1	1
Injury	1	1
Depression	1	1
Non-union Bone Fracture	1	1
Impaired Healing	1	1
Inadequate Pain Relief	1	1
Sore Throat	1	1
Cancer	1	1
Lymphoma	1	1
Constipation	1	1
Shaking/Tremors	1	1
Sleep Dysfunction	1	1
Vascular System (Circulation), Impaired	1	1
Drug Resistant Bacterial Infection	1	1
Reaction to Medicinal Component of Device	1	1
Increased Sensitivity	1	1
Presyncope	1	1
No Information	1	1
Vitamin Deficiency	1	1
Malunion of Bone	1	1
Arthritis	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1
Abscess	1	1

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