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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
2019 1 1
2023 3 3
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Packaging Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unstable 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Cyst(s) 2 2
Foreign Body In Patient 2 2
Numbness 2 2
Swelling/ Edema 2 2
Ambulation Difficulties 2 2
Adhesion(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Scar Tissue 1 1
Joint Contracture 1 1
Bacterial Infection 1 1
Deformity/ Disfigurement 1 1

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