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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
2018 574 574
2019 678 678
2020 738 738
2021 898 898
2022 980 980
2023 1069 1069

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2462 2462
Material Twisted/Bent 1150 1150
Device-Device Incompatibility 535 535
Material Deformation 322 322
Naturally Worn 295 295
Crack 222 222
Entrapment of Device 90 90
Fracture 82 82
Material Integrity Problem 68 68
Mechanical Jam 68 68
Mechanical Problem 62 62
Appropriate Term/Code Not Available 40 40
Component Missing 36 36
Scratched Material 33 33
Contamination /Decontamination Problem 32 32
Physical Resistance/Sticking 28 28
Unintended Movement 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Material Split, Cut or Torn 17 17
Detachment of Device or Device Component 15 15
Device Slipped 13 13
Connection Problem 12 12
Calibration Problem 11 11
Structural Problem 11 11
Material Fragmentation 10 10
Corroded 7 7
Difficult to Remove 7 7
No Apparent Adverse Event 7 7
Insufficient Information 6 6
Use of Device Problem 6 6
Loose or Intermittent Connection 6 6
Device Contamination with Chemical or Other Material 5 5
Failure to Cut 4 4
Difficult to Insert 4 4
Bent 3 3
Material Discolored 3 3
Improper or Incorrect Procedure or Method 3 3
Separation Problem 3 3
Illegible Information 3 3
Device Handling Problem 2 2
Fitting Problem 2 2
Defective Component 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Device Issue 2 2
Dull, Blunt 2 2
Incomplete or Missing Packaging 1 1
Device Damaged Prior to Use 1 1
Material Separation 1 1
Sticking 1 1
Disconnection 1 1
Thermal Decomposition of Device 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Component Incompatible 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Migration 1 1
Device Fell 1 1
Defective Device 1 1
Compatibility Problem 1 1
Device Difficult to Maintain 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 2926 2926
No Consequences Or Impact To Patient 1629 1629
Insufficient Information 137 137
Not Applicable 116 116
No Code Available 101 101
Foreign Body In Patient 56 56
No Known Impact Or Consequence To Patient 47 47
No Patient Involvement 35 35
No Information 17 17
Injury 6 6
Local Reaction 3 3
Bone Fracture(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Limb Fracture 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Nerve Damage 1 1
Burn(s) 1 1
Spinal Cord Injury 1 1
Blood Loss 1 1

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