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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
2023 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 671 671
Insufficient Information 101 101
Device Dislodged or Dislocated 71 71
Malposition of Device 62 62
Patient Device Interaction Problem 48 48
Patient-Device Incompatibility 38 38
Migration 31 31
Noise, Audible 28 28
Inadequacy of Device Shape and/or Size 28 28
Fracture 25 25
Migration or Expulsion of Device 19 19
Loose or Intermittent Connection 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
Positioning Problem 11 11
Material Integrity Problem 9 9
Installation-Related Problem 8 8
Positioning Failure 8 8
Appropriate Term/Code Not Available 7 7
Osseointegration Problem 5 5
Difficult to Insert 5 5
Break 5 5
Particulates 5 5
Fitting Problem 5 5
Retraction Problem 4 4
Device Appears to Trigger Rejection 4 4
Material Erosion 4 4
Biocompatibility 3 3
Incorrect Device Or Component Shipped 3 3
Naturally Worn 3 3
Material Protrusion/Extrusion 2 2
No Apparent Adverse Event 2 2
Inaccurate Information 2 2
Loss of Osseointegration 2 2
Device Markings/Labelling Problem 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 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 Remove 1 1
Difficult To Position 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 292 292
Unspecified Infection 171 171
No Information 119 119
Insufficient Information 98 98
Loss of Range of Motion 89 89
Ossification 87 87
Joint Disorder 81 81
Joint Dislocation 67 67
No Clinical Signs, Symptoms or Conditions 63 63
Failure of Implant 57 57
Implant Pain 54 54
Swelling/ Edema 45 45
Swelling 45 45
Difficulty Chewing 44 44
Limited Mobility Of The Implanted Joint 37 37
Nerve Damage 35 35
Headache 35 35
Hypersensitivity/Allergic reaction 33 33
No Code Available 33 33
Ankylosis 27 27
Discomfort 27 27
Bacterial Infection 26 26
Inadequate Pain Relief 22 22
Numbness 20 20
Scar Tissue 19 19
Reaction 14 14
Facial Nerve Paralysis 12 12
No Known Impact Or Consequence To Patient 10 10
Itching Sensation 9 9
Deformity/ Disfigurement 9 9
No Consequences Or Impact To Patient 8 8
Bone Fracture(s) 8 8
Hearing Loss 7 7
Blurred Vision 7 7
Hematoma 6 6
Feeding Problem 6 6
Erythema 6 6
Abscess 6 6
Inadequate Osseointegration 6 6
Sleep Dysfunction 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Sensitivity of Teeth 5 5
Fibrosis 5 5
No Patient Involvement 5 5
Purulent Discharge 5 5
Fistula 5 5
Dysphasia 5 5
Necrosis 5 5
Muscle Spasm(s) 4 4
Neurological Deficit/Dysfunction 4 4
Perforation 4 4
Rupture 4 4
Osteolysis 4 4
Arthralgia 4 4
Scar Excision 4 4
Foreign Body Reaction 4 4
Hearing Impairment 4 4
Dysphagia/ Odynophagia 4 4
Debris, Bone Shedding 4 4
Rheumatoid Arthritis 4 4
Vertigo 4 4
Increased Sensitivity 4 4
Drug Resistant Bacterial Infection 3 3
Organ Dehiscence 3 3
Osteopenia/ Osteoporosis 3 3
Metal Related Pathology 3 3
Difficulty Chewing 3 3
Joint Laxity 3 3
Wound Dehiscence 3 3
Adhesion(s) 3 3
Inflammation 3 3
Scarring 3 3
Seizures 2 2
Increased Sensitivity 2 2
Skin Discoloration 2 2
Pocket Erosion 2 2
Muscle Weakness 2 2
Non-union Bone Fracture 2 2
Myalgia 2 2
Urticaria 2 2
Tinnitus 2 2
Laceration(s) 2 2
Granuloma 2 2
Arthritis 2 2
Autoimmune Reaction 2 2
Erosion 2 2
Edema 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Osteomyelitis 2 2
Foreign Body In Patient 2 2
Cancer 2 2
Post Operative Wound Infection 2 2
Irritability 2 2
Obstruction/Occlusion 1 1
Neck Pain 1 1
Fluid Discharge 1 1
Skin Tears 1 1
Weight Changes 1 1
Presyncope 1 1
Bruxism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Leibinger GmbH & Co. KG II Mar-08-2023
2 TMJ Solutions Inc II Apr-19-2018
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