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TPLC
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Device
pin, fixation, resorbable, hard tissue
Definition
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Product Code
OVZ
Regulation Number
888.3040
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET, INC.
SUBSTANTIALLY EQUIVALENT
1
DEPUY ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
4
4
2016
6
6
2017
1
1
2018
1
1
2021
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
6
6
Migration or Expulsion of Device
2
2
Component Missing
2
2
Break
2
2
Detachment Of Device Component
1
1
Component Falling
1
1
Difficult or Delayed Positioning
1
1
Material Disintegration
1
1
Split
1
1
Device Operates Differently Than Expected
1
1
Material Integrity Problem
1
1
Insufficient Information
1
1
Migration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
6
6
No Known Impact Or Consequence To Patient
4
4
Device Embedded In Tissue or Plaque
2
2
No Consequences Or Impact To Patient
2
2
Pain
2
2
Swelling
1
1
Tissue Damage
1
1
Wound Dehiscence
1
1
Foreign Body Reaction
1
1
Granuloma
1
1
Ulcer
1
1
No Code Available
1
1
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