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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, wrist, carpal trapezium
Product CodeKYI
Regulation Number 888.3770
Device Class 2


Premarket Reviews
ManufacturerDecision
ENSEMBLE ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 4 4
2019 14 14
2020 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Appropriate Term/Code Not Available 7 7
Break 3 3
Migration or Expulsion of Device 2 2
Insufficient Information 2 2
Metal Shedding Debris 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
Pain 7 7
Joint Dislocation 6 6
No Known Impact Or Consequence To Patient 3 3
Test Result 1 1
Limited Mobility Of The Implanted Joint 1 1
Patient Problem/Medical Problem 1 1
Swelling 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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