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TPLC
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show TPLC since
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Device
prosthesis, toe, constrained, polymer
Product Code
KWH
Regulation Number
888.3720
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K102601
ORTHOFLEX ROD
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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