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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, cutting, orthopedic
Product CodeHTZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 109 109
2020 87 87
2021 229 229
2022 196 196
2023 188 188
2024 158 158

Device Problems MDRs with this Device Problem Events in those MDRs
Break 307 307
Device-Device Incompatibility 235 235
Material Deformation 150 150
Naturally Worn 136 136
Material Twisted/Bent 38 38
Scratched Material 38 38
Mechanical Jam 32 32
Corroded 31 31
Crack 25 25
Material Integrity Problem 22 22
Physical Resistance/Sticking 22 22
Contamination /Decontamination Problem 15 15
Detachment of Device or Device Component 13 13
Illegible Information 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Mechanical Problem 11 11
Failure to Cut 9 9
Activation, Positioning or Separation Problem 8 8
Difficult to Remove 5 5
Patient-Device Incompatibility 5 5
Material Frayed 5 5
Structural Problem 4 4
Entrapment of Device 4 4
Material Discolored 4 4
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 3 3
Unintended Movement 3 3
No Apparent Adverse Event 2 2
Incorrect Measurement 2 2
Connection Problem 2 2
Failure to Disconnect 2 2
Sharp Edges 2 2
Device Damaged by Another Device 2 2
Use of Device Problem 2 2
Device Dislodged or Dislocated 1 1
Self-Activation or Keying 1 1
Difficult to Open or Close 1 1
Difficult to Advance 1 1
Loose or Intermittent Connection 1 1
Degraded 1 1
Material Fragmentation 1 1
Device Slipped 1 1
Display Difficult to Read 1 1
Positioning Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 711 711
No Consequences Or Impact To Patient 134 134
Insufficient Information 73 73
No Patient Involvement 20 20
Not Applicable 10 10
No Code Available 10 10
No Known Impact Or Consequence To Patient 10 10
Foreign Body In Patient 4 4
Unspecified Tissue Injury 3 3
Post Operative Wound Infection 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 1 1
Joint Dislocation 1 1
Failure of Implant 1 1
Paralysis 1 1
Nerve Damage 1 1
Pain 1 1
Cerebrospinal Fluid Leakage 1 1
Spinal Cord Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Feb-13-2020
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