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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
2016 24 24
2017 12 12
2018 11 11
2019 17 17
2020 9 9
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Adverse Event Without Identified Device or Use Problem 11 11
Fracture 6 6
Material Fragmentation 5 5
Device Contamination with Chemical or Other Material 2 2
Dull, Blunt 2 2
Bent 2 2
Failure to Obtain Sample 1 1
Contamination /Decontamination Problem 1 1
Device-Device Incompatibility 1 1
Material Deformation 1 1
Crack 1 1
Material Separation 1 1
Failure to Align 1 1
Device Operates Differently Than Expected 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Torn Material 1 1
Insufficient Information 1 1
Detachment Of Device Component 1 1
Entrapment of Device 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 24 24
No Consequences Or Impact To Patient 16 16
No Code Available 15 15
No Patient Involvement 7 7
Foreign Body In Patient 4 4
Device Embedded In Tissue or Plaque 3 3
No Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Injury 2 2
Unspecified Tissue Injury 1 1
Patient Problem/Medical Problem 1 1
Nerve Damage 1 1
Weakness 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Decreased Sensitivity 1 1
Insufficient Information 1 1
Fatigue 1 1
Paresis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Apr-24-2020
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