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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, toe, constrained, polymer
Product CodeKWH
Regulation Number 888.3720
Device Class 2


Premarket Reviews
ManufacturerDecision
BRM EXTREMITIES
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONESUSA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-PRO LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 6 6
2016 6 6
2017 3 3
2018 7 7
2019 15 15
2020 8 8
2021 5 5
2022 5 5
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 19 19
Break 11 11
Fracture 7 7
Device Dislodged or Dislocated 4 4
Device Disinfection Or Sterilization Issue 3 3
Insufficient Information 3 3
Migration or Expulsion of Device 3 3
Delivered as Unsterile Product 2 2
Crack 2 2
Use of Device Problem 2 2
Appropriate Term/Code Not Available 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Material Integrity Problem 2 2
Device Expiration Issue 2 2
Device Operates Differently Than Expected 2 2
Device Markings/Labelling Problem 1 1
Material Fragmentation 1 1
Migration 1 1
Inaccurate Information 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Osseointegration 1 1
Cut In Material 1 1
Failure to Align 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Component or Accessory Incompatibility 1 1
Detachment of Device or Device Component 1 1
Disconnection 1 1
Device Reprocessing Problem 1 1
Shelf Life Exceeded 1 1
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
Failure of Implant 9 9
Pain 9 9
Unspecified Infection 6 6
No Information 6 6
No Code Available 6 6
Patient Problem/Medical Problem 3 3
Injury 3 3
No Consequences Or Impact To Patient 2 2
Implant Pain 2 2
Osteolysis 2 2
Post Operative Wound Infection 2 2
No Patient Involvement 2 2
Bone Fracture(s) 2 2
Foreign Body In Patient 2 2
Inadequate Osseointegration 1 1
Osteopenia/ Osteoporosis 1 1
Ambulation Difficulties 1 1
Reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Joint Laxity 1 1
Discomfort 1 1
Tissue Damage 1 1
Joint Swelling 1 1
Disability 1 1
Joint Dislocation 1 1
Inflammation 1 1
Muscular Rigidity 1 1
Wound Dehiscence 1 1
Rheumatoid Arthritis 1 1
Fall 1 1
Foreign Body Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sgarlato Med, LLC II Aug-04-2010
2 Tornier, Inc. II Nov-24-2009
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