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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
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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