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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Break 156 156
Fracture 47 47
Material Twisted/Bent 24 24
Material Deformation 12 12
Entrapment of Device 8 8
Material Fragmentation 5 5
Device-Device Incompatibility 4 4
Contamination /Decontamination Problem 3 3
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Use of Device Problem 2 2
Illegible Information 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Mechanical Problem 2 2
Difficult to Insert 1 1
Material Discolored 1 1
Component Missing 1 1
Device Slipped 1 1
Defective Device 1 1
Material Separation 1 1
Incorrect Measurement 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 130 130
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
Insufficient Information 7 7
No Patient Involvement 6 6
No Code Available 4 4
Injury 2 2
Failure of Implant 1 1
Perforation 1 1
Spinal Column Injury 1 1
Unspecified Tissue Injury 1 1
Spinal Cord Injury 1 1
Excessive Tear Production 1 1

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