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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tap, bone
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 85 85
2021 91 91
2022 91 91
2023 84 84
2024 84 84
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 188 188
Device-Device Incompatibility 150 150
Contamination /Decontamination Problem 39 39
Fracture 28 28
Entrapment of Device 12 12
Crack 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Material Fragmentation 6 6
Failure to Cut 5 5
Material Integrity Problem 5 5
Mechanical Jam 4 4
Dull, Blunt 3 3
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Material Separation 3 3
Naturally Worn 2 2
Material Deformation 2 2
Use of Device Problem 2 2
Difficult to Remove 2 2
Material Split, Cut or Torn 2 2
No Apparent Adverse Event 2 2
Fitting Problem 1 1
Device Slipped 1 1
Illegible Information 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Expulsion 1 1
Compatibility Problem 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 333 333
No Consequences Or Impact To Patient 42 42
Foreign Body In Patient 24 24
No Patient Involvement 24 24
Insufficient Information 18 18
No Known Impact Or Consequence To Patient 5 5
Bone Fracture(s) 4 4
Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Post Operative Wound Infection 1 1

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