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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
2019 2011 2011
2020 1644 1644
2021 2000 2000
2022 1721 1726
2023 1735 1735
2024 179 179

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3447 3447
Material Twisted/Bent 2198 2198
Device-Device Incompatibility 1264 1264
Fracture 691 691
Naturally Worn 544 544
Material Deformation 540 540
Calibration Problem 244 244
Material Integrity Problem 192 192
Contamination /Decontamination Problem 166 166
Entrapment of Device 109 109
Mechanical Jam 83 83
Crack 82 82
Mechanical Problem 81 81
Detachment of Device or Device Component 69 69
Compatibility Problem 66 66
Material Fragmentation 59 59
Connection Problem 55 55
Use of Device Problem 42 42
Packaging Problem 34 34
Unintended Movement 33 33
Appropriate Term/Code Not Available 33 33
Physical Resistance/Sticking 31 31
Adverse Event Without Identified Device or Use Problem 26 26
Component Missing 26 26
Device Slipped 21 21
No Apparent Adverse Event 21 21
Delivered as Unsterile Product 19 19
Device Contamination with Chemical or Other Material 19 19
Defective Device 17 17
Material Separation 17 22
Difficult to Remove 16 16
Scratched Material 14 14
Loose or Intermittent Connection 13 13
Corroded 13 13
Illegible Information 11 11
Dull, Blunt 10 10
Failure to Calibrate 9 9
Device Damaged Prior to Use 9 9
Fitting Problem 7 7
Material Disintegration 7 7
Electrical /Electronic Property Problem 7 7
Device Reprocessing Problem 6 6
Degraded 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Device Difficult to Maintain 6 6
Noise, Audible 6 6
Material Split, Cut or Torn 6 6
Device Handling Problem 5 5
Device Damaged by Another Device 5 5
Structural Problem 5 5
Activation, Positioning or Separation Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Defective Component 4 4
Mechanics Altered 4 4
Insufficient Information 4 4
Incomplete or Inadequate Connection 4 4
Separation Problem 3 3
Failure to Cut 3 3
Deformation Due to Compressive Stress 3 3
Failure to Discharge 3 3
Labelling, Instructions for Use or Training Problem 2 2
Positioning Failure 2 2
Unstable 2 2
Peeled/Delaminated 2 2
Solder Joint Fracture 2 2
Failure to Disconnect 2 2
Positioning Problem 2 2
Device Sensing Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Fell 2 2
Unclear Information 1 1
Thickening of Material 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Premature Separation 1 1
Sharp Edges 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Power Problem 1 1
Output Problem 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1
Dent in Material 1 1
Device Markings/Labelling Problem 1 1
Off-Label Use 1 1
Device Difficult to Program or Calibrate 1 1
Misassembled 1 1
Nonstandard Device 1 1
Failure to Cycle 1 1
Contamination 1 1
Accessory Incompatible 1 1
Inadequate Instructions for Healthcare Professional 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5390 5395
No Consequences Or Impact To Patient 1837 1837
No Patient Involvement 686 686
No Known Impact Or Consequence To Patient 506 506
Insufficient Information 339 339
Foreign Body In Patient 237 237
No Code Available 200 200
Device Embedded In Tissue or Plaque 92 92
Not Applicable 87 87
No Information 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Injury 21 21
Failure of Implant 9 9
Unspecified Tissue Injury 9 9
Patient Problem/Medical Problem 8 8
Hemorrhage/Bleeding 5 5
Pain 4 4
Perforation of Vessels 3 3
Blood Loss 3 3
Spinal Cord Injury 2 2
Skull Fracture 2 2
Exsanguination 2 2
Bone Fracture(s) 2 2
Ossification 1 1
Paralysis 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Tissue Damage 1 1
Impaired Healing 1 1
Joint Laxity 1 1
Skin Inflammation/ Irritation 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 Trilliant Surgical, LLC II Jan-10-2020
4 Zimmer Biomet, Inc. II Jul-04-2019
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