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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device awl
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWJ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2021 9 9
2022 10 10
2023 9 9
2024 17 17
2025 17 17
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Material Deformation 8 8
Failure to Cut 7 7
Contamination /Decontamination Problem 5 5
Material Twisted/Bent 4 4
Entrapment of Device 2 2
Degraded 2 2
Fracture 2 2
Naturally Worn 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
Scratched Material 1 1
Delivered as Unsterile Product 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Insufficient Information 9 9
Foreign Body In Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Aug-28-2023
2 SEASPINE ORTHOPEDICS CORPORATION II Jul-15-2024
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