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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pin, fixation, resorbable, hard tissue
Definition Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Product CodeOVZ
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Break 2 2
Migration or Expulsion of Device 2 2
Component Missing 2 2
Component Falling 1 1
Detachment Of Device Component 1 1
Material Disintegration 1 1
Insufficient Information 1 1
Difficult or Delayed Positioning 1 1
Migration 1 1
Device Operates Differently Than Expected 1 1
Split 1 1
Material Integrity Problem 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
Pain 2 2
No Consequences Or Impact To Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Wound Dehiscence 1 1
No Code Available 1 1
Foreign Body Reaction 1 1
Swelling 1 1
Tissue Damage 1 1
Ulcer 1 1
Granuloma 1 1

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