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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)
2019
2020
2021
2022
2023
2024
1
2
1
1
1
0
MDR Year
MDR Reports
MDR Events
2019
204
204
2020
255
255
2021
207
207
2022
192
192
2023
236
236
2024
50
50
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
757
757
Device Dislodged or Dislocated
72
72
Patient Device Interaction Problem
66
66
Malposition of Device
60
60
Insufficient Information
58
58
Patient-Device Incompatibility
37
37
Noise, Audible
34
34
Fracture
32
32
Inadequacy of Device Shape and/or Size
27
27
Migration
26
26
Loosening of Implant Not Related to Bone-Ingrowth
24
24
Migration or Expulsion of Device
16
16
Loose or Intermittent Connection
12
12
Positioning Problem
12
12
Device Appears to Trigger Rejection
11
11
Material Integrity Problem
9
9
No Apparent Adverse Event
9
9
Installation-Related Problem
7
7
Positioning Failure
7
7
Loss of Osseointegration
6
6
Appropriate Term/Code Not Available
6
6
Osseointegration Problem
5
5
Fitting Problem
5
5
Difficult to Insert
5
5
Particulates
5
5
Material Erosion
4
4
Break
3
3
Use of Device Problem
3
3
Naturally Worn
3
3
Inaccurate Information
2
2
Detachment of Device or Device Component
2
2
Device-Device Incompatibility
2
2
Material Protrusion/Extrusion
2
2
Nonstandard Device
2
2
Device Slipped
1
1
Unexpected Therapeutic Results
1
1
Unstable
1
1
Component Incompatible
1
1
Contamination
1
1
Difficult or Delayed Positioning
1
1
Flaked
1
1
Expiration Date Error
1
1
Improper or Incorrect Procedure or Method
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
337
337
Unspecified Infection
176
176
Insufficient Information
129
129
No Clinical Signs, Symptoms or Conditions
102
102
Loss of Range of Motion
101
101
Joint Dislocation
86
86
No Information
81
81
Swelling/ Edema
75
75
Ossification
72
72
Failure of Implant
58
58
Implant Pain
56
56
Joint Disorder
55
55
Ankylosis
43
43
Swelling
38
38
Hypersensitivity/Allergic reaction
35
35
Nerve Damage
31
31
Bacterial Infection
31
31
No Code Available
30
30
Difficulty Chewing
30
30
Headache
23
23
Numbness
23
23
Discomfort
23
23
Inadequate Pain Relief
22
22
Limited Mobility Of The Implanted Joint
21
21
Scar Tissue
18
18
Reaction
9
9
Hearing Impairment
9
9
Inadequate Osseointegration
9
9
No Known Impact Or Consequence To Patient
8
8
Cramp(s) /Muscle Spasm(s)
8
8
Difficulty Chewing
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Bone Fracture(s)
8
8
Facial Nerve Paralysis
8
8
Osteolysis
8
8
Deformity/ Disfigurement
8
8
Joint Laxity
7
7
Sleep Dysfunction
6
6
Obstruction/Occlusion
6
6
Blurred Vision
6
6
Feeding Problem
6
6
Abscess
6
6
Hematoma
6
6
Erythema
6
6
Itching Sensation
5
5
Fistula
5
5
Perforation
5
5
Dysphasia
5
5
Sensitivity of Teeth
5
5
Fibrosis
5
5
Metal Related Pathology
4
4
Increased Sensitivity
4
4
Foreign Body In Patient
4
4
Rupture
4
4
Arthralgia
4
4
Scar Excision
4
4
Vertigo
4
4
Necrosis
4
4
Dysphagia/ Odynophagia
4
4
Adhesion(s)
4
4
Arthritis
4
4
Rheumatoid Arthritis
4
4
Neurological Deficit/Dysfunction
4
4
Hearing Loss
4
4
Inflammation
3
3
Wound Dehiscence
3
3
Purulent Discharge
3
3
Foreign Body Reaction
3
3
Tinnitus
3
3
No Consequences Or Impact To Patient
3
3
Eye Pain
3
3
Drug Resistant Bacterial Infection
3
3
Osteopenia/ Osteoporosis
3
3
No Patient Involvement
2
2
Post Operative Wound Infection
2
2
Fluid Discharge
2
2
Cancer
2
2
Skin Inflammation/ Irritation
2
2
Osteomyelitis
2
2
Bruxism
2
2
Urticaria
2
2
Non-union Bone Fracture
2
2
Irritability
2
2
Rash
2
2
Pocket Erosion
2
2
Scarring
2
2
Seizures
2
2
Increased Sensitivity
2
2
Skin Discoloration
2
2
Edema
2
2
Autoimmune Reaction
2
2
Laceration(s)
2
2
Muscle Weakness
2
2
Granuloma
2
2
High Blood Pressure/ Hypertension
2
2
Low Blood Pressure/ Hypotension
1
1
Hemorrhage/Bleeding
1
1
Erosion
1
1
Cellulitis
1
1
Airway Obstruction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Leibinger GmbH & Co. KG
II
Mar-08-2023
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