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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device joint, temporomandibular, implant
Definition Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Product CodeLZD
Regulation Number 872.3940
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
0 1 2 1 1 0

MDR Year MDR Reports MDR Events
2018 210 210
2019 204 204
2020 255 255
2021 207 207
2022 192 192

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 653 653
Insufficient Information 93 93
Device Dislodged or Dislocated 67 67
Malposition of Device 61 61
Patient Device Interaction Problem 45 45
Patient-Device Incompatibility 36 36
Migration 31 31
Noise, Audible 28 28
Inadequacy of Device Shape and/or Size 26 26
Fracture 25 25
Loose or Intermittent Connection 16 16
Migration or Expulsion of Device 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Positioning Problem 11 11
Material Integrity Problem 9 9
Positioning Failure 8 8
Installation-Related Problem 8 8
Appropriate Term/Code Not Available 7 7
Osseointegration Problem 5 5
Difficult to Insert 5 5
Break 5 5
Particulates 5 5
Material Erosion 4 4
Fitting Problem 4 4
Device Appears to Trigger Rejection 4 4
Retraction Problem 4 4
Biocompatibility 3 3
Incorrect Device Or Component Shipped 3 3
Material Protrusion/Extrusion 2 2
Loss of Osseointegration 2 2
Device Markings/Labelling Problem 2 2
Use of Device Problem 2 2
No Apparent Adverse Event 2 2
Inaccurate Information 2 2
Difficult to Remove 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Defective Component 1 1
Naturally Worn 1 1
Flaked 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Failure To Adhere Or Bond 1 1
Biofilm coating in Device 1 1
Difficult To Position 1 1
Nonstandard Device 1 1
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 277 277
Unspecified Infection 169 169
No Information 119 119
Ossification 85 85
Loss of Range of Motion 83 83
Insufficient Information 82 82
Joint Disorder 81 81
Joint Dislocation 64 64
No Clinical Signs, Symptoms or Conditions 58 58
Failure of Implant 52 52
Implant Pain 52 52
Swelling 45 45
Difficulty Chewing 44 44
Swelling/ Edema 39 39
Limited Mobility Of The Implanted Joint 37 37
Headache 35 35
Nerve Damage 35 35
No Code Available 33 33
Hypersensitivity/Allergic reaction 33 33
Ankylosis 27 27
Discomfort 27 27
Bacterial Infection 24 24
Inadequate Pain Relief 22 22
Numbness 20 20
Scar Tissue 18 18
Reaction 14 14
Facial Nerve Paralysis 12 12
No Known Impact Or Consequence To Patient 10 10
Deformity/ Disfigurement 9 9
Itching Sensation 9 9
No Consequences Or Impact To Patient 8 8
Bone Fracture(s) 8 8
Blurred Vision 7 7
Hearing Loss 7 7
Hematoma 6 6
Feeding Problem 6 6
Sleep Dysfunction 6 6
Erythema 6 6
Inadequate Osseointegration 6 6
Fibrosis 5 5
No Patient Involvement 5 5
Purulent Discharge 5 5
Fistula 5 5
Dysphasia 5 5
Sensitivity of Teeth 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Necrosis 5 5
Foreign Body Reaction 4 4
Debris, Bone Shedding 4 4
Arthralgia 4 4
Increased Sensitivity 4 4
Vertigo 4 4
Muscle Spasm(s) 4 4
Neurological Deficit/Dysfunction 4 4
Dysphagia/ Odynophagia 4 4
Abscess 4 4
Rheumatoid Arthritis 4 4
Hearing Impairment 4 4
Perforation 4 4
Rupture 4 4
Scar Excision 4 4
Osteopenia/ Osteoporosis 3 3
Wound Dehiscence 3 3
Scarring 3 3
Drug Resistant Bacterial Infection 3 3
Organ Dehiscence 3 3
Inflammation 3 3
Osteolysis 3 3
Difficulty Chewing 3 3
Osteomyelitis 2 2
Arthritis 2 2
Erosion 2 2
Non-union Bone Fracture 2 2
Foreign Body In Patient 2 2
Edema 2 2
Tinnitus 2 2
Myalgia 2 2
Irritability 2 2
Post Operative Wound Infection 2 2
Seizures 2 2
Urticaria 2 2
Pocket Erosion 2 2
Granuloma 2 2
Adhesion(s) 2 2
Laceration(s) 2 2
Autoimmune Reaction 2 2
Increased Sensitivity 2 2
Skin Discoloration 2 2
Muscle Weakness 2 2
Cancer 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Neck Pain 1 1
High Blood Pressure/ Hypertension 1 1
Skin Irritation 1 1
Rash 1 1
Airway Obstruction 1 1
Fatigue 1 1
Fungus 1 1
Diarrhea 1 1
Paralysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 TMJ Solutions Inc II Apr-19-2018
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