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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 1

MDR Year MDR Reports MDR Events
2018 210 210
2019 204 204
2020 255 255
2021 207 207
2022 192 192
2023 203 203

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 780 780
Insufficient Information 105 105
Device Dislodged or Dislocated 83 83
Malposition of Device 69 69
Patient Device Interaction Problem 60 60
Patient-Device Incompatibility 43 43
Inadequacy of Device Shape and/or Size 34 34
Migration 34 34
Noise, Audible 34 34
Fracture 32 32
Loosening of Implant Not Related to Bone-Ingrowth 21 21
Migration or Expulsion of Device 18 18
Loose or Intermittent Connection 16 16
Positioning Problem 12 12
Material Integrity Problem 9 9
Device Appears to Trigger Rejection 9 9
Positioning Failure 8 8
Installation-Related Problem 8 8
No Apparent Adverse Event 8 8
Appropriate Term/Code Not Available 7 7
Fitting Problem 7 7
Loss of Osseointegration 6 6
Break 5 5
Particulates 5 5
Difficult to Insert 5 5
Osseointegration Problem 5 5
Material Erosion 4 4
Retraction Problem 4 4
Use of Device Problem 3 3
Biocompatibility 3 3
Nonstandard Device 3 3
Naturally Worn 3 3
Incorrect Device Or Component Shipped 3 3
Detachment of Device or Device Component 2 2
Device Markings/Labelling Problem 2 2
Device-Device Incompatibility 2 2
Material Protrusion/Extrusion 2 2
Inaccurate Information 2 2
Device Handling Problem 1 1
Difficult To Position 1 1
Difficult to Remove 1 1
Flaked 1 1
Failure To Adhere Or Bond 1 1
Biofilm coating in Device 1 1
Component Incompatible 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Expiration Date Error 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 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 360 360
Unspecified Infection 197 197
No Information 119 119
Insufficient Information 112 112
Loss of Range of Motion 102 102
Ossification 95 95
Joint Dislocation 88 88
No Clinical Signs, Symptoms or Conditions 88 88
Joint Disorder 81 81
Swelling/ Edema 63 63
Failure of Implant 58 58
Implant Pain 56 56
Swelling 45 45
Difficulty Chewing 44 44
Headache 40 40
Ankylosis 39 39
Hypersensitivity/Allergic reaction 38 38
Limited Mobility Of The Implanted Joint 37 37
Nerve Damage 35 35
Bacterial Infection 33 33
No Code Available 33 33
Discomfort 29 29
Inadequate Pain Relief 22 22
Numbness 22 22
Scar Tissue 20 20
Reaction 14 14
Facial Nerve Paralysis 12 12
No Known Impact Or Consequence To Patient 10 10
Inadequate Osseointegration 9 9
Itching Sensation 9 9
Deformity/ Disfigurement 9 9
Osteolysis 8 8
No Consequences Or Impact To Patient 8 8
Hearing Impairment 8 8
Bone Fracture(s) 8 8
Difficulty Chewing 8 8
Joint Laxity 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Hearing Loss 7 7
Blurred Vision 7 7
Hematoma 6 6
Feeding Problem 6 6
Erythema 6 6
Abscess 6 6
Sleep Dysfunction 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
Perforation 5 5
Neurological Deficit/Dysfunction 4 4
Muscle Spasm(s) 4 4
Tinnitus 4 4
Vertigo 4 4
Arthralgia 4 4
Scar Excision 4 4
Rupture 4 4
Foreign Body Reaction 4 4
Inflammation 4 4
Dysphagia/ Odynophagia 4 4
Debris, Bone Shedding 4 4
Adhesion(s) 4 4
Arthritis 4 4
Rheumatoid Arthritis 4 4
Foreign Body In Patient 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Metal Related Pathology 4 4
Increased Sensitivity 4 4
Drug Resistant Bacterial Infection 3 3
Eye Pain 3 3
Obstruction/Occlusion 3 3
Organ Dehiscence 3 3
Osteopenia/ Osteoporosis 3 3
Wound Dehiscence 3 3
Rash 3 3
Scarring 3 3
Seizures 2 2
Increased Sensitivity 2 2
Skin Discoloration 2 2
Muscle Weakness 2 2
Pocket Erosion 2 2
Myalgia 2 2
Urticaria 2 2
Non-union Bone Fracture 2 2
Edema 2 2
Autoimmune Reaction 2 2
Erosion 2 2
Laceration(s) 2 2
High Blood Pressure/ Hypertension 2 2
Granuloma 2 2
Fluid Discharge 2 2
Post Operative Wound Infection 2 2
Irritability 2 2
Bruxism 2 2
Cancer 2 2
Skin Inflammation/ Irritation 2 2
Osteomyelitis 2 2

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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