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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device countersink
Product CodeHWW
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 4 4
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3 3
Material Fragmentation 3 3
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 3 3
No Information 2 2
Unspecified Infection 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer GmbH II May-23-2019
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