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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
Product CodeHSZ
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2014 18 18
2015 20 20
2016 27 27
2017 24 24
2018 13 13
2019 5 5
2020 13 13
2021 27 27
2022 35 35
2023 39 39
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 86 86
Failure to Cut 25 25
Air Leak 22 22
Material Rupture 21 21
Entrapment of Device 17 17
Leak/Splash 13 13
Device Operates Differently Than Expected 9 9
Overheating of Device 8 8
Burst Container or Vessel 7 7
Device-Device Incompatibility 5 5
Noise, Audible 5 5
Device Inoperable 5 5
Fracture 4 4
Detachment Of Device Component 3 3
Excessive Heating 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Deformation 2 2
Output below Specifications 2 2
Use of Device Problem 2 2
Mechanical Jam 2 2
Vibration 2 2
Partial Blockage 2 2
Dull, Blunt 1 1
Component Falling 1 1
Fluid/Blood Leak 1 1
Temperature Problem 1 1
Hole In Material 1 1
Device Displays Incorrect Message 1 1
Naturally Worn 1 1
Connection Problem 1 1
Intermittent Continuity 1 1
No Apparent Adverse Event 1 1
Sticking 1 1
Material Integrity Problem 1 1
Disassembly 1 1
Defective Component 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Crack 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Power Problem 1 1
Failure to Align 1 1
Component Missing 1 1
Improper Flow or Infusion 1 1
Contamination /Decontamination Problem 1 1
Physical Resistance/Sticking 1 1
Mechanical Problem 1 1
Fitting Problem 1 1
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 87 87
No Known Impact Or Consequence To Patient 54 54
No Consequences Or Impact To Patient 28 28
Foreign Body In Patient 18 18
No Patient Involvement 18 18
No Code Available 6 6
Insufficient Information 6 6
No Information 5 5
Device Embedded In Tissue or Plaque 3 3
Burn(s) 2 2
Hearing Impairment 1 1
Unspecified Infection 1 1
Superficial (First Degree) Burn 1 1
Foreign Body Reaction 1 1
Laceration(s) 1 1
Pain 1 1
Tinnitus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Mar-01-2024
2 The Anspach Effort, Inc. II May-04-2017
3 The Anspach Effort, Inc. II Jul-03-2014
4 The Anspach Effort, Inc. II Jan-09-2014
5 The Anspach Effort, Inc. II Nov-13-2013
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