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TPLC
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show TPLC since
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2024
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Device
prosthesis, toe, hemi-, phalangeal
Product Code
KWD
Regulation Number
888.3730
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
4
4
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
4
4
Improper or Incorrect Procedure or Method
3
3
Loose or Intermittent Connection
2
2
Difficult to Insert
2
2
Use of Device Problem
2
2
Defective Device
2
2
Patient Device Interaction Problem
1
1
Appropriate Term/Code Not Available
1
1
Failure to Osseointegrate
1
1
Material Deformation
1
1
Detachment of Device or Device Component
1
1
Loss of Osseointegration
1
1
Malposition of Device
1
1
Insufficient Information
1
1
Material Integrity Problem
1
1
Defective Component
1
1
Device Appears to Trigger Rejection
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
No Known Impact Or Consequence To Patient
4
4
Swelling
4
4
Deformity/ Disfigurement
4
4
No Code Available
3
3
No Clinical Signs, Symptoms or Conditions
3
3
Osteolysis
3
3
Insufficient Information
3
3
Inadequate Osseointegration
2
2
Swelling/ Edema
2
2
Abdominal Pain
1
1
Skin Infection
1
1
Complaint, Ill-Defined
1
1
Metal Related Pathology
1
1
Adhesion(s)
1
1
Reaction to Medicinal Component of Device
1
1
Fever
1
1
Foreign Body In Patient
1
1
Erythema
1
1
Skin Inflammation
1
1
Joint Swelling
1
1
Loss of Range of Motion
1
1
Scar Tissue
1
1
Ambulation Difficulties
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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