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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device probe
Product CodeHXB
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 69 69
2020 39 39
2021 35 35
2022 41 41
2023 47 47
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 149 149
Fracture 43 43
Material Twisted/Bent 24 24
Material Deformation 9 9
Entrapment of Device 8 8
Device-Device Incompatibility 4 4
Material Fragmentation 4 4
Contamination /Decontamination Problem 3 3
Material Split, Cut or Torn 3 3
Illegible Information 2 2
No Apparent Adverse Event 2 2
Detachment of Device or Device Component 2 2
Use of Device Problem 2 2
Material Integrity Problem 2 2
Mechanical Problem 2 2
Material Separation 1 1
Device Slipped 1 1
Material Discolored 1 1
Difficult to Insert 1 1
Incorrect Measurement 1 1
Device Dislodged or Dislocated 1 1
Component Missing 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 119
No Known Impact Or Consequence To Patient 41 41
No Consequences Or Impact To Patient 30 30
Foreign Body In Patient 27 27
Device Embedded In Tissue or Plaque 9 9
No Patient Involvement 6 6
No Code Available 4 4
Insufficient Information 4 4
Injury 2 2
Spinal Cord Injury 1 1
Excessive Tear Production 1 1
Failure of Implant 1 1
Perforation 1 1
Spinal Column Injury 1 1
Unspecified Tissue Injury 1 1

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