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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screwdriver
Product CodeHXX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 1369 1369
2018 1468 1468
2019 2011 2011
2020 1644 1644
2021 2003 2003
2022 1143 1143

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4027 4027
Material Twisted/Bent 1635 1635
Device-Device Incompatibility 963 963
Fracture 613 613
Material Deformation 588 588
Naturally Worn 541 541
Calibration Problem 231 231
Dull, Blunt 202 202
Appropriate Term/Code Not Available 179 179
Contamination /Decontamination Problem 137 137
Material Integrity Problem 131 131
Material Fragmentation 121 121
Entrapment of Device 92 92
Crack 90 90
Mechanical Problem 87 87
Mechanical Jam 79 79
Device Contamination with Chemical or Other Material 72 72
Detachment of Device or Device Component 68 68
Connection Problem 63 63
Bent 61 61
Device Operates Differently Than Expected 52 52
Compatibility Problem 52 52
Peeled/Delaminated 39 39
Use of Device Problem 39 39
Packaging Problem 35 35
Physical Resistance/Sticking 33 33
Component Missing 32 32
Difficult to Remove 30 30
Adverse Event Without Identified Device or Use Problem 29 29
Unintended Movement 25 25
Failure To Adhere Or Bond 24 24
Loose or Intermittent Connection 23 23
Detachment Of Device Component 21 21
Fitting Problem 20 20
Delivered as Unsterile Product 19 19
Defective Device 18 18
Device Slipped 17 17
Material Separation 15 15
Insufficient Information 14 14
Disassembly 13 13
Corroded 12 12
Device Damaged Prior to Use 12 12
Failure to Calibrate 9 9
Material Split, Cut or Torn 9 9
Material Disintegration 8 8
Structural Problem 7 7
Device Difficult to Maintain 7 7
Illegible Information 7 7
Scratched Material 7 7
Material Distortion 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Electrical /Electronic Property Problem 6 6
Device Reprocessing Problem 6 6
Degraded 5 5
Defective Component 5 5
Device Damaged by Another Device 5 5
Separation Problem 5 5
No Apparent Adverse Event 5 5
Noise, Audible 5 5
Device Handling Problem 4 4
Incomplete or Inadequate Connection 4 4
Device Dislodged or Dislocated 4 4
Sticking 4 4
Failure to Align 4 4
Unsealed Device Packaging 4 4
Failure to Discharge 3 3
Material Discolored 3 3
Deformation Due to Compressive Stress 3 3
Device Issue 3 3
Failure to Cut 3 3
Inadequacy of Device Shape and/or Size 3 3
Mechanics Altered 3 3
Activation, Positioning or SeparationProblem 3 3
Device Markings/Labelling Problem 3 3
Device Sensing Problem 2 2
Device Operational Issue 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Fell 2 2
Microbial Contamination of Device 2 2
Device Inoperable 2 2
Unstable 2 2
Dent in Material 2 2
Split 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Solder Joint Fracture 2 2
Positioning Failure 2 2
Component Incompatible 2 2
Misassembled 2 2
Fluid Leak 2 2
Difficult to Insert 2 2
Labelling, Instructions for Use or Training Problem 1 1
Kinked 1 1
Misconnection 1 1
Device Difficult to Program or Calibrate 1 1
Contamination 1 1
Component Falling 1 1
Complete Blockage 1 1
Calibration Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3197 3197
No Consequences Or Impact To Patient 2698 2698
No Known Impact Or Consequence To Patient 1512 1512
No Patient Involvement 1083 1083
No Information 360 360
No Code Available 353 353
Foreign Body In Patient 242 242
Not Applicable 191 191
Device Embedded In Tissue or Plaque 153 153
Insufficient Information 121 121
Injury 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Patient Problem/Medical Problem 17 17
Failure of Implant 12 12
Blood Loss 5 5
Unspecified Tissue Injury 5 5
Bone Fracture(s) 3 3
Sedation 3 3
Pain 3 3
Local Reaction 3 3
Skull Fracture 2 2
Exsanguination 2 2
Perforation of Vessels 2 2
Joint Laxity 1 1
Foreign Body Reaction 1 1
Ossification 1 1
Dysphagia/ Odynophagia 1 1
Unspecified Infection 1 1
Irritation 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Tissue Damage 1 1
Paralysis 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Spinal Cord Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jul-19-2022
2 Flower Orthopedics Corporation II Jun-01-2021
3 Synthes (USA) Products LLC II May-23-2018
4 Trilliant Surgical, LLC II Jan-10-2020
5 Zimmer Biomet, Inc. II Jul-04-2019
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