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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 driver, prosthesis
Product CodeHWR
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 678 678
2020 738 738
2021 898 898
2022 980 980
2023 1281 1281
2024 525 525

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2489 2489
Material Twisted/Bent 1347 1347
Device-Device Incompatibility 637 637
Naturally Worn 335 335
Material Deformation 287 287
Crack 207 207
Entrapment of Device 98 98
Fracture 78 78
Mechanical Jam 72 72
Material Integrity Problem 69 69
Mechanical Problem 65 65
Contamination /Decontamination Problem 40 40
Scratched Material 33 33
Physical Resistance/Sticking 28 28
Component Missing 27 27
Unintended Movement 24 24
Adverse Event Without Identified Device or Use Problem 18 18
Appropriate Term/Code Not Available 17 17
Detachment of Device or Device Component 17 17
Device Slipped 13 13
Structural Problem 12 12
No Apparent Adverse Event 12 12
Material Split, Cut or Torn 11 11
Calibration Problem 11 11
Corroded 9 9
Connection Problem 8 8
Failure to Cut 6 6
Use of Device Problem 6 6
Loose or Intermittent Connection 5 5
Difficult to Remove 5 5
Device Contamination with Chemical or Other Material 3 3
Improper or Incorrect Procedure or Method 3 3
Material Fragmentation 3 3
Illegible Information 3 3
Device Handling Problem 2 2
Difficult to Insert 2 2
Flaked 2 2
Material Discolored 2 2
Defective Device 2 2
Defective Component 2 2
Material Separation 1 1
Separation Failure 1 1
Compatibility Problem 1 1
Moisture or Humidity Problem 1 1
Device Reprocessing Problem 1 1
Component Incompatible 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Off-Label Use 1 1
Migration 1 1
Insufficient Information 1 1
Device Difficult to Maintain 1 1
Device Fell 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3555 3555
No Consequences Or Impact To Patient 1118 1118
Insufficient Information 243 243
No Code Available 95 95
Not Applicable 63 63
Foreign Body In Patient 62 62
No Patient Involvement 35 35
No Known Impact Or Consequence To Patient 34 34
No Information 12 12
Injury 5 5
Limb Fracture 4 4
Device Embedded In Tissue or Plaque 2 2
Pain 2 2
Bone Fracture(s) 2 2
Failure of Implant 1 1
Nerve Damage 1 1
Neuropathy 1 1
Spinal Cord Injury 1 1
Burn(s) 1 1
Foreign Body Reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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