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TPLC
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Device
prosthesis, wrist, carpal trapezium
Product Code
KYI
Regulation Number
888.3770
Device Class
2
Premarket Reviews
Manufacturer
Decision
ENSEMBLE ORTHOPEDICS, LLC
SUBSTANTIALLY EQUIVALENT
1
1. K201072
Ensemble CMC, Size 141, Ensemble CMC, Size 151, En
...
MDR Year
MDR Reports
MDR Events
2019
14
14
2020
8
8
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
8
8
Appropriate Term/Code Not Available
7
7
Insufficient Information
2
2
Break
2
2
Migration or Expulsion of Device
1
1
Nonstandard Device
1
1
Device Dislodged or Dislocated
1
1
Material Integrity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
9
9
Joint Dislocation
6
6
Pain
4
4
No Known Impact Or Consequence To Patient
2
2
Unspecified Tissue Injury
1
1
Patient Problem/Medical Problem
1
1
Bone Fracture(s)
1
1
Unspecified Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Wright Medical Technology, Inc.
II
Nov-25-2019
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