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TPLC
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show TPLC since
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Device
screw, fixation, bone, non-spinal, metallic
Product Code
NDJ
Regulation Number
888.3040
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
326
326
2015
48
48
2016
4
4
2017
4
4
2018
8
8
2019
22
22
2020
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
220
220
Loss of Osseointegration
131
131
Adverse Event Without Identified Device or Use Problem
77
77
Osseointegration Problem
24
24
Appropriate Term/Code Not Available
14
14
Malposition of Device
11
11
Metal Shedding Debris
11
11
Break
5
5
Inadequacy of Device Shape and/or Size
5
5
Loose or Intermittent Connection
5
5
Loss of or Failure to Bond
5
5
Migration or Expulsion of Device
3
3
Device Dislodged or Dislocated
2
2
Entrapment of Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Migration
1
1
Difficult to Advance
1
1
Corroded
1
1
Fracture
1
1
Component Falling
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
160
160
Pain
149
149
No Information
119
119
No Code Available
57
57
Discomfort
36
36
Foreign Body Reaction
27
27
Inadequate Osseointegration
22
22
Host-Tissue Reaction
21
21
Inflammation
19
19
Limited Mobility Of The Implanted Joint
15
15
Pulmonary Embolism
12
12
Tissue Damage
12
12
Osteolysis
12
12
Bone Fracture(s)
11
11
Cardiac Arrest
10
10
Infarction, Cerebral
9
9
Ambulation Difficulties
8
8
Fall
6
6
Hypersensitivity/Allergic reaction
6
6
Not Applicable
5
5
Cyst(s)
4
4
Necrosis
4
4
Loss of Range of Motion
4
4
Swelling
4
4
Adhesion(s)
3
3
Edema
3
3
Weakness
3
3
Injury
3
3
Erosion
3
3
Synovitis
2
2
Scar Tissue
2
2
Abscess
2
2
Deformity/ Disfigurement
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Hematoma
1
1
Sepsis
1
1
Muscle Spasm(s)
1
1
Muscular Rigidity
1
1
Joint Swelling
1
1
Nerve Damage
1
1
Fatigue
1
1
Toxicity
1
1
Anxiety
1
1
Fibrosis
1
1
No Consequences Or Impact To Patient
1
1
Distress
1
1
Sleep Dysfunction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet Microfixation, Inc.
III
Jan-23-2012
2
Zimmer, Inc.
II
May-29-2015
3
Zimmer, Inc.
II
Feb-20-2014
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