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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 804 804

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2617 2617
Material Twisted/Bent 1410 1410
Device-Device Incompatibility 686 686
Naturally Worn 374 374
Material Deformation 294 294
Crack 215 215
Entrapment of Device 102 102
Fracture 78 78
Mechanical Jam 76 76
Material Integrity Problem 72 72
Mechanical Problem 67 67
Contamination /Decontamination Problem 41 41
Scratched Material 34 34
Physical Resistance/Sticking 28 28
Component Missing 27 27
Unintended Movement 27 27
Failure to Cut 26 26
Adverse Event Without Identified Device or Use Problem 19 19
Detachment of Device or Device Component 18 18
Appropriate Term/Code Not Available 17 17
No Apparent Adverse Event 14 14
Device Slipped 14 14
Structural Problem 12 12
Material Split, Cut or Torn 11 11
Calibration Problem 11 11
Corroded 9 9
Connection Problem 8 8
Use of Device Problem 6 6
Material Fragmentation 5 5
Loose or Intermittent Connection 5 5
Difficult to Remove 5 5
Material Discolored 4 4
Illegible Information 3 3
Improper or Incorrect Procedure or Method 3 3
Device Contamination with Chemical or Other Material 3 3
Defective Device 2 2
Device Handling Problem 2 2
Flaked 2 2
Defective Component 2 2
Difficult to Insert 2 2
Separation Failure 1 1
Insufficient Information 1 1
Device Fell 1 1
Device Difficult to Maintain 1 1
Material Separation 1 1
Separation Problem 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Device Reprocessing Problem 1 1
Moisture or Humidity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3760 3760
No Consequences Or Impact To Patient 1118 1118
Insufficient Information 322 322
No Code Available 95 95
Foreign Body In Patient 67 67
Not Applicable 63 63
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
Bone Fracture(s) 2 2
Pain 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Foreign Body Reaction 1 1
Nerve Damage 1 1
Spinal Cord Injury 1 1
Neuropathy 1 1
Burn(s) 1 1

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