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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wire, fixation, intraosseous
Product CodeDZK
Regulation Number 872.4880
Device Class 2


Premarket Reviews
ManufacturerDecision
RUSSELL B. WALTHER
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 7 7
2016 1 1
2018 2 2
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Insufficient Information 2 2
Fitting Problem 1 1
Malposition of Device 1 1
Failure to Align 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Bent 1 1
Failure to Advance 1 1
Overheating of Device 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 8 8
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Code Available 1 1
Muscle/Tendon Damage 1 1
Inflammation 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1

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