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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
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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