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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
2014 16 16
2015 18 18
2016 24 24
2017 12 12
2018 11 11
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 86 86
Material Fragmentation 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Fracture 8 8
Failure to Cut 7 7
Material Deformation 6 6
Material Twisted/Bent 4 4
Detachment Of Device Component 4 4
Bent 3 3
Entrapment of Device 3 3
Contamination /Decontamination Problem 3 3
Device Operates Differently Than Expected 2 2
Device Contamination with Chemical or Other Material 2 2
Dull, Blunt 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Difficult to Remove 1 1
Material Separation 1 1
Sticking 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Failure to Align 1 1
Failure to Obtain Sample 1 1
Corroded 1 1
Crack 1 1
Material Integrity Problem 1 1
Device-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Naturally Worn 1 1
Scratched Material 1 1
Torn Material 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 44 44
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 22 22
No Code Available 16 16
No Patient Involvement 10 10
Foreign Body In Patient 7 7
Device Embedded In Tissue or Plaque 6 6
No Information 5 5
Insufficient Information 5 5
Injury 2 2
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Fatigue 1 1
Nerve Damage 1 1
Paresis 1 1
Weakness 1 1
Unspecified Tissue Injury 1 1
Patient Problem/Medical Problem 1 1
Decreased Sensitivity 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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