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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
2014 11 11
2015 33 33
2016 44 44
2017 58 58
2018 63 63
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 297 297
Fracture 76 76
Material Twisted/Bent 39 39
Bent 19 19
Material Deformation 15 15
Material Fragmentation 8 8
Entrapment of Device 8 8
Device-Device Incompatibility 4 4
Detachment Of Device Component 4 4
Material Split, Cut or Torn 3 3
Crack 3 3
Material Integrity Problem 3 3
Difficult to Remove 3 3
Contamination /Decontamination Problem 3 3
Mechanical Problem 3 3
Naturally Worn 3 3
Defective Device 2 2
Use of Device Problem 2 2
Component Missing 2 2
Detachment of Device or Device Component 2 2
Illegible Information 2 2
No Apparent Adverse Event 2 2
Device Operates Differently Than Expected 2 2
Device Slipped 1 1
Split 1 1
Material Discolored 1 1
Material Separation 1 1
Incorrect Measurement 1 1
Output below Specifications 1 1
Difficult to Insert 1 1
Physical Resistance/Sticking 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 149 149
No Clinical Signs, Symptoms or Conditions 130 130
No Consequences Or Impact To Patient 58 58
Device Embedded In Tissue or Plaque 35 35
Foreign Body In Patient 34 34
No Patient Involvement 27 27
No Information 19 19
No Code Available 8 8
Insufficient Information 7 7
Injury 4 4
Not Applicable 3 3
Failure of Implant 1 1
Perforation 1 1
Local Reaction 1 1
Blood Loss 1 1
Spinal Column Injury 1 1
Unspecified Tissue Injury 1 1
Spinal Cord Injury 1 1
Excessive Tear Production 1 1

Recalls
Manufacturer Recall Class Date Posted
1 SpineFrontier, Inc. II Jan-03-2014
2 Zimmer Trabecular Metal Technology, Inc. II Dec-23-2014
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