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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, compression
Product CodeHWN
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 21 21
2015 8 8
2016 16 16
2017 29 29
2018 21 21
2019 37 37
2020 51 51
2021 88 88
2022 64 64
2023 83 83
2024 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Break 224 224
Device-Device Incompatibility 75 75
Crack 45 45
Naturally Worn 43 43
Material Deformation 26 26
Material Twisted/Bent 21 21
Scratched Material 11 11
Mechanical Jam 11 11
Component Missing 10 10
Material Fragmentation 10 10
Structural Problem 10 10
Fracture 10 10
Contamination /Decontamination Problem 9 9
Detachment of Device or Device Component 9 9
Appropriate Term/Code Not Available 8 8
Entrapment of Device 8 8
Material Too Rigid or Stiff 4 4
Fitting Problem 4 4
Difficult to Open or Close 3 3
Device Slipped 3 3
Difficult to Insert 3 3
Unintended Movement 3 3
Failure to Align 2 2
Connection Problem 2 2
Device Dislodged or Dislocated 2 2
Bent 2 2
Material Integrity Problem 2 2
Insufficient Information 2 2
Physical Resistance/Sticking 2 2
Mechanical Problem 2 2
Corroded 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 2 2
Material Erosion 1 1
Torn Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Operates Differently Than Expected 1 1
No Apparent Adverse Event 1 1
Device Reprocessing Problem 1 1
Failure To Adhere Or Bond 1 1
Difficult to Remove 1 1
Material Frayed 1 1
Flare or Flash 1 1
Sparking 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 268 268
No Consequences Or Impact To Patient 83 83
No Known Impact Or Consequence To Patient 42 42
Insufficient Information 25 25
No Information 19 19
No Patient Involvement 19 19
Foreign Body In Patient 14 14
No Code Available 9 9
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Swelling 2 2
Osteolysis 2 2
Erosion 2 2
Unspecified Infection 1 1
Not Applicable 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Inc. II Dec-01-2010
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