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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 96 96
Fracture 38 38
Break 31 31
Device Dislodged or Dislocated 17 17
Naturally Worn 13 13
Device Contamination with Chemical or Other Material 4 4
Material Invagination 4 4
Inadequacy of Device Shape and/or Size 3 3
Material Deformation 3 3
Migration 2 2
Loss of or Failure to Bond 2 2
Loss of Osseointegration 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Degraded 2 2
Appropriate Term/Code Not Available 2 2
Labelling, Instructions for Use or Training Problem 1 1
Device Markings/Labelling Problem 1 1
Material Erosion 1 1
Insufficient Information 1 1
Loose or Intermittent Connection 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 80 80
Insufficient Information 35 35
Loss of Range of Motion 19 19
Implant Pain 14 14
Unspecified Infection 13 13
Pain 13 13
Joint Laxity 12 12
No Known Impact Or Consequence To Patient 10 10
No Code Available 9 9
No Clinical Signs, Symptoms or Conditions 7 7
Joint Dislocation 6 6
Injury 6 6
Osteolysis 6 6
Malunion of Bone 5 5
Deformity/ Disfigurement 5 5
Bone Fracture(s) 4 4
Nerve Damage 3 3
Inadequate Osseointegration 2 2
Swelling/ Edema 2 2
No Consequences Or Impact To Patient 2 2
Debris, Bone Shedding 1 1
Hypersensitivity/Allergic reaction 1 1
Rheumatoid Arthritis 1 1
Arthralgia 1 1
Synovitis 1 1
Numbness 1 1
Discomfort 1 1
Fall 1 1
Limb Fracture 1 1
Non-union Bone Fracture 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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