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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tap, bone
Product CodeHWX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 125 125
2020 85 85
2021 91 91
2022 91 91
2023 84 84
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 227 227
Device-Device Incompatibility 156 156
Contamination /Decontamination Problem 35 35
Fracture 25 25
Entrapment of Device 15 15
Adverse Event Without Identified Device or Use Problem 8 8
Failure to Cut 6 6
Material Fragmentation 6 6
Crack 5 5
Material Integrity Problem 5 5
Material Twisted/Bent 4 4
Appropriate Term/Code Not Available 3 3
Use of Device Problem 3 3
Dull, Blunt 3 3
Device Handling Problem 3 3
Mechanical Jam 3 3
Naturally Worn 2 2
Detachment of Device or Device Component 2 2
Material Split, Cut or Torn 2 2
No Apparent Adverse Event 2 2
Difficult to Remove 2 2
Compatibility Problem 1 1
Corroded 1 1
Migration 1 1
Device Difficult to Maintain 1 1
Device Slipped 1 1
Difficult to Insert 1 1
Material Separation 1 1
Expulsion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Fitting Problem 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
No Consequences Or Impact To Patient 114 114
No Patient Involvement 57 57
Foreign Body In Patient 25 25
No Known Impact Or Consequence To Patient 12 12
No Code Available 10 10
Insufficient Information 9 9
Injury 5 5
Bone Fracture(s) 3 3
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 2 2
Not Applicable 1 1
Patient Problem/Medical Problem 1 1
Unspecified Infection 1 1
Nerve Damage 1 1
Post Operative Wound Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer GmbH II May-23-2019
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