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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device instrument, cutting, orthopedic
Product CodeHTZ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 32 32
2018 47 47
2019 109 109
2020 87 87
2021 230 230
2022 139 139

Device Problems MDRs with this Device Problem Events in those MDRs
Break 199 199
Device-Device Incompatibility 125 125
Material Deformation 84 84
Naturally Worn 76 76
Material Twisted/Bent 42 42
Mechanical Jam 28 28
Scratched Material 26 26
Corroded 24 24
Physical Resistance/Sticking 22 22
Crack 15 15
Material Integrity Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Mechanical Problem 11 11
Contamination /Decontamination Problem 11 11
Appropriate Term/Code Not Available 9 9
Activation, Positioning or SeparationProblem 8 8
Detachment of Device or Device Component 8 8
Difficult to Remove 7 7
Illegible Information 7 7
Failure to Cut 5 5
Material Frayed 5 5
Loose or Intermittent Connection 4 4
Connection Problem 4 4
Cut In Material 3 3
Device Issue 2 2
Device Operates Differently Than Expected 2 2
Device Damaged by Another Device 2 2
Incorrect Measurement 2 2
Material Discolored 2 2
Entrapment of Device 2 2
Sharp Edges 2 2
Bent 1 1
Display Difficult to Read 1 1
Degraded 1 1
Disassembly 1 1
Difficult to Insert 1 1
Material Separation 1 1
Use of Device Problem 1 1
Component Missing 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Dull, Blunt 1 1
Off-Label Use 1 1
Structural Problem 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 368 368
No Consequences Or Impact To Patient 168 168
No Known Impact Or Consequence To Patient 30 30
No Patient Involvement 27 27
Insufficient Information 17 17
No Code Available 16 16
Not Applicable 14 14
No Information 10 10
Foreign Body In Patient 3 3
Unspecified Infection 2 2
Pain 1 1
Injury 1 1
Disability 1 1
Joint Dislocation 1 1
Unspecified Tissue Injury 1 1
Failure of Implant 1 1

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