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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, toe, hemi-, phalangeal
Product CodeKWD
Regulation Number 888.3730
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUFIX SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCUFIX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPOLY, LLC
  SUBSTANTIALLY EQUIVALENT 2
MONTROSS EXTREMITY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1
VILEX IN TENNESSEE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 19 19
2020 4 4
2021 2 2
2022 10 10
2023 27 27
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 39 39
Break 8 8
Off-Label Use 3 3
Improper or Incorrect Procedure or Method 3 3
Use of Device Problem 2 2
Difficult to Insert 2 2
Loose or Intermittent Connection 2 2
Defective Device 2 2
Malposition of Device 1 1
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Device Appears to Trigger Rejection 1 1
Failure to Osseointegrate 1 1
Defective Component 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Implant Pain 21 21
Pain 11 11
Inadequate Pain Relief 6 6
Failure of Implant 5 5
Deformity/ Disfigurement 4 4
No Known Impact Or Consequence To Patient 4 4
Swelling 4 4
No Code Available 3 3
Osteolysis 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Swelling/ Edema 2 2
Reaction to Medicinal Component of Device 1 1
Metal Related Pathology 1 1
Skin Infection 1 1
Skin Inflammation 1 1
Ambulation Difficulties 1 1
Inadequate Osseointegration 1 1
Foreign Body In Patient 1 1
Complaint, Ill-Defined 1 1
Joint Swelling 1 1
Loss of Range of Motion 1 1
Scar Tissue 1 1
Abdominal Pain 1 1
Adhesion(s) 1 1
Erythema 1 1
Fever 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioPro, Inc. II Feb-28-2022
2 Wright Medical Technology, Inc. II Nov-25-2019
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