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TPLC
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show TPLC since
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Device
dispenser, cement
Product Code
KIH
Regulation Number
888.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
29
29
2020
23
23
2021
30
30
2022
26
26
2023
30
30
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
50
50
Mechanical Jam
19
19
Leak/Splash
17
17
Failure to Eject
11
11
Chemical Problem
9
9
Appropriate Term/Code Not Available
8
8
Device-Device Incompatibility
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Mechanics Altered
6
6
Defective Device
5
5
Loss of or Failure to Bond
4
4
Entrapment of Device
3
3
Defective Component
3
3
Device Contaminated During Manufacture or Shipping
2
2
Material Deformation
2
2
Connection Problem
2
2
Device Slipped
1
1
Mechanical Problem
1
1
Migration or Expulsion of Device
1
1
Off-Label Use
1
1
Malposition of Device
1
1
Output Problem
1
1
Pumping Problem
1
1
Expiration Date Error
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Difficult to Remove
1
1
Material Twisted/Bent
1
1
Packaging Problem
1
1
Failure to Prime
1
1
Material Separation
1
1
Explosion
1
1
Fracture
1
1
Naturally Worn
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
68
68
No Consequences Or Impact To Patient
35
35
Insufficient Information
9
9
Pain
7
7
Extravasation
7
7
No Known Impact Or Consequence To Patient
5
5
No Code Available
4
4
Foreign Body In Patient
4
4
Device Embedded In Tissue or Plaque
3
3
Necrosis
2
2
Abrasion
2
2
No Patient Involvement
2
2
Non-union Bone Fracture
2
2
Neuropathy
1
1
Weight Changes
1
1
Failure of Implant
1
1
Adhesion(s)
1
1
Inflammation
1
1
Synovitis
1
1
Edema
1
1
Hair Loss
1
1
Dysphagia/ Odynophagia
1
1
Joint Laxity
1
1
Paraplegia
1
1
Spinal Cord Injury
1
1
Nervous System Injury
1
1
Vertebral Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Apr-01-2019
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