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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device awl
Product CodeHWJ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 17 17
2020 9 9
2021 9 9
2022 10 10
2023 9 9
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 28 28
Adverse Event Without Identified Device or Use Problem 9 9
Failure to Cut 7 7
Material Deformation 6 6
Contamination /Decontamination Problem 3 3
Entrapment of Device 3 3
Material Twisted/Bent 3 3
Dull, Blunt 2 2
Fracture 2 2
Delivered as Unsterile Product 1 1
Device Damaged Prior to Use 1 1
Material Integrity Problem 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Code Available 12 12
No Consequences Or Impact To Patient 8 8
Insufficient Information 5 5
Foreign Body In Patient 4 4
Injury 2 2
No Patient Involvement 2 2
Decreased Sensitivity 1 1
Hypoesthesia 1 1
Fatigue 1 1
Nerve Damage 1 1
Paresis 1 1
Weakness 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Aug-28-2023
2 K2M, Inc II Apr-24-2020
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