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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 2
BRM EXTREMITIES SRL
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KERI MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOTEC LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 14 14
2015 18 18
2016 6 6
2017 14 14
2018 11 11
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 88 88
Break 62 62
Fracture 50 50
Device Dislodged or Dislocated 18 18
Naturally Worn 13 13
Device Contamination with Chemical or Other Material 5 5
Material Deformation 5 5
Material Integrity Problem 4 4
Appropriate Term/Code Not Available 4 4
Material Invagination 4 4
Inadequacy of Device Shape and/or Size 4 4
Loss of or Failure to Bond 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Migration 2 2
Loss of Osseointegration 2 2
Degraded 2 2
Material Discolored 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Detachment Of Device Component 1 1
Cut In Material 1 1
Biocompatibility 1 1
Device Markings/Labelling Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Scratched Material 1 1
Torn Material 1 1
Insufficient Information 1 1
Incorrect Device Or Component Shipped 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 75 75
Insufficient Information 35 35
Pain 24 24
No Code Available 23 23
No Information 22 22
No Known Impact Or Consequence To Patient 19 19
Loss of Range of Motion 19 19
Unspecified Infection 13 13
Implant Pain 13 13
Joint Laxity 12 12
Injury 11 11
No Clinical Signs, Symptoms or Conditions 6 6
Osteolysis 6 6
Deformity/ Disfigurement 5 5
Joint Dislocation 5 5
Malunion of Bone 5 5
Swelling 4 4
No Consequences Or Impact To Patient 3 3
Discomfort 3 3
Bone Fracture(s) 3 3
Nerve Damage 3 3
Inadequate Osseointegration 2 2
Swelling/ Edema 2 2
Erythema 2 2
Fall 1 1
Arthritis 1 1
Rheumatoid Arthritis 1 1
Debris, Bone Shedding 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Arthralgia 1 1
Synovitis 1 1
Device Embedded In Tissue or Plaque 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Numbness 1 1
No Patient Involvement 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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