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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, finger, constrained, polymer
Product CodeKYJ
Regulation Number 888.3230
Device Class 2


Premarket Reviews
ManufacturerDecision
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRM EXTREMITIES SRL
  SUBSTANTIALLY EQUIVALENT 1
KERI MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 26 26
2020 48 48
2021 45 45
2022 39 39
2023 24 24
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 84 84
Fracture 37 37
Break 30 30
Device Dislodged or Dislocated 17 17
Naturally Worn 13 13
Device Contamination with Chemical or Other Material 4 4
Material Invagination 4 4
Material Deformation 3 3
Inadequacy of Device Shape and/or Size 3 3
Loss of Osseointegration 2 2
Degraded 2 2
Loss of or Failure to Bond 2 2
Appropriate Term/Code Not Available 2 2
Migration 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Loose or Intermittent Connection 1 1
Material Erosion 1 1
Labelling, Instructions for Use or Training Problem 1 1
Biocompatibility 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 70 70
Insufficient Information 35 35
Loss of Range of Motion 19 19
Unspecified Infection 13 13
Pain 13 13
Implant Pain 13 13
Joint Laxity 12 12
No Known Impact Or Consequence To Patient 10 10
No Code Available 9 9
Osteolysis 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Injury 6 6
Joint Dislocation 5 5
Deformity/ Disfigurement 5 5
Malunion of Bone 5 5
Nerve Damage 3 3
Bone Fracture(s) 2 2
No Consequences Or Impact To Patient 2 2
Swelling/ Edema 2 2
Inadequate Osseointegration 2 2
Numbness 1 1
Discomfort 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1
Hypersensitivity/Allergic reaction 1 1
Rheumatoid Arthritis 1 1
Debris, Bone Shedding 1 1
Fall 1 1
Synovitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra Lifesciences Sales Llc II Dec-16-2019
2 Wright Medical Technology, Inc. II Nov-25-2019
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