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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
MDR Year
MDR Reports
MDR Events
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
15
15
Break
7
7
Fracture
5
5
Device Dislodged or Dislocated
2
2
Material Integrity Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Migration
1
1
Inaccurate Information
1
1
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Crack
1
1
Material Fragmentation
1
1
Migration or Expulsion of Device
1
1
Loss of Osseointegration
1
1
Failure to Align
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
9
9
Failure of Implant
7
7
Unspecified Infection
4
4
Pain
3
3
No Consequences Or Impact To Patient
2
2
No Code Available
2
2
Osteolysis
2
2
Post Operative Wound Infection
2
2
Implant Pain
2
2
Patient Problem/Medical Problem
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Clinical Signs, Symptoms or Conditions
1
1
No Patient Involvement
1
1
Inadequate Osseointegration
1
1
Osteopenia/ Osteoporosis
1
1
Foreign Body In Patient
1
1
Joint Laxity
1
1
Muscular Rigidity
1
1
Discomfort
1
1
Injury
1
1
Rheumatoid Arthritis
1
1
Fall
1
1
Foreign Body Reaction
1
1
Bone Fracture(s)
1
1
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