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TPLC
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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 Code
LZD
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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