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TPLC
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Device
joint, temporomandibular, implant
Regulation Description
Total temporomandibular joint prosthesis.
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)
2020
2021
2022
2023
2024
2025
2
1
1
1
2
0
MDR Year
MDR Reports
MDR Events
2020
255
255
2021
207
207
2022
193
193
2023
236
236
2024
207
207
2025
97
97
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
794
794
Device Dislodged or Dislocated
86
86
Malposition of Device
72
72
Patient Device Interaction Problem
65
65
Insufficient Information
57
57
Fracture
36
36
Inadequacy of Device Shape and/or Size
34
34
Device Appears to Trigger Rejection
32
32
Patient-Device Incompatibility
30
30
Noise, Audible
29
29
Migration
26
26
Loosening of Implant Not Related to Bone-Ingrowth
25
25
Migration or Expulsion of Device
16
16
Loss of Osseointegration
15
15
Positioning Problem
13
13
No Apparent Adverse Event
10
10
Fitting Problem
10
10
Difficult to Insert
7
7
Positioning Failure
7
7
Material Integrity Problem
6
6
Appropriate Term/Code Not Available
6
6
Installation-Related Problem
5
5
Loose or Intermittent Connection
5
5
Use of Device Problem
4
4
Unintended Movement
4
4
Osseointegration Problem
4
4
Product Quality Problem
2
2
Detachment of Device or Device Component
2
2
Nonstandard Device
2
2
Naturally Worn
2
2
Component Incompatible
2
2
Device-Device Incompatibility
2
2
Component Missing
1
1
Contamination
1
1
Material Perforation
1
1
Use of Incorrect Control/Treatment Settings
1
1
Device Handling Problem
1
1
Expiration Date Error
1
1
Activation, Positioning or Separation Problem
1
1
Unstable
1
1
Device Slipped
1
1
Unexpected Therapeutic Results
1
1
Connection Problem
1
1
Flaked
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
357
357
Insufficient Information
190
190
Unspecified Infection
177
177
No Clinical Signs, Symptoms or Conditions
140
140
Loss of Range of Motion
124
124
Joint Dislocation
115
115
Swelling/ Edema
95
95
Ossification
61
61
Failure of Implant
61
61
No Information
60
60
Ankylosis
59
59
Implant Pain
59
59
Bacterial Infection
43
43
Hypersensitivity/Allergic reaction
36
36
Joint Disorder
27
27
Inadequate Pain Relief
22
22
Discomfort
21
21
Numbness
21
21
Difficulty Chewing
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Inadequate Osseointegration
17
17
Scar Tissue
16
16
Headache
15
15
Obstruction/Occlusion
15
15
Swelling
14
14
Limited Mobility Of The Implanted Joint
14
14
Nerve Damage
14
14
Difficulty Chewing
12
12
Deformity/ Disfigurement
12
12
Osteolysis
10
10
Hearing Impairment
9
9
Cramp(s) /Muscle Spasm(s)
8
8
Bone Fracture(s)
8
8
Joint Laxity
8
8
Facial Nerve Paralysis
8
8
Itching Sensation
7
7
Fistula
7
7
Reaction
6
6
Abscess
6
6
Fluid Discharge
6
6
Bruxism
6
6
Feeding Problem
6
6
Perforation
5
5
Erythema
5
5
Peripheral Nervous Injury
4
4
Vertigo
4
4
Arthritis
4
4
Increased Sensitivity
4
4
Foreign Body In Patient
4
4
Paresthesia
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Leibinger GmbH & Co. KG
II
Mar-08-2023
2
TMJ Solutions Inc
II
Sep-26-2024
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