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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device starter, bone screw
Product CodeHWD
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 3 3
2017 3 3
2018 3 3
2019 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 4 4
Packaging Problem 2 2
Device Operates Differently Than Expected 2 2
Break 2 2
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Unstable 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Device Embedded In Tissue or Plaque 2 2
No Consequences Or Impact To Patient 2 2
Deformity/ Disfigurement 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
Nervous System Injury 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Pain 1 1
Scar Tissue 1 1
No Information 1 1
No Code Available 1 1
Joint Contracture 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-03-2011
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