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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 442 442

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3538 3538
Material Twisted/Bent 2298 2298
Device-Device Incompatibility 1314 1314
Fracture 715 715
Material Deformation 551 551
Naturally Worn 547 547
Calibration Problem 247 247
Material Integrity Problem 202 202
Contamination /Decontamination Problem 171 171
Entrapment of Device 112 112
Mechanical Jam 87 87
Crack 86 86
Mechanical Problem 83 83
Detachment of Device or Device Component 70 70
Compatibility Problem 66 66
Material Fragmentation 59 59
Connection Problem 55 55
Use of Device Problem 43 43
Packaging Problem 34 34
Appropriate Term/Code Not Available 34 34
Unintended Movement 33 33
Physical Resistance/Sticking 31 31
Component Missing 26 26
Adverse Event Without Identified Device or Use Problem 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 19 19
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
Electrical /Electronic Property Problem 8 8
Material Disintegration 7 7
Fitting Problem 7 7
Structural Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Device Reprocessing Problem 6 6
Degraded 6 6
Device Difficult to Maintain 6 6
Material Split, Cut or Torn 6 6
Noise, Audible 6 6
Device Handling Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Device Damaged by Another Device 5 5
Activation, Positioning or Separation Problem 5 5
Mechanics Altered 4 4
Defective Component 4 4
Insufficient Information 4 4
Incomplete or Inadequate Connection 4 4
Separation Problem 3 3
Failure to Discharge 3 3
Failure to Cut 3 3
Deformation Due to Compressive Stress 3 3
Solder Joint Fracture 2 2
Failure to Disconnect 2 2
Device Sensing Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Positioning Failure 2 2
Unstable 2 2
Peeled/Delaminated 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
Power Problem 2 2
Device Fell 2 2
Sharp Edges 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Premature Separation 1 1
Unclear Information 1 1
Thickening of Material 1 1
Off-Label Use 1 1
Device Difficult to Program or Calibrate 1 1
Misassembled 1 1
Nonstandard Device 1 1
Shipping Damage or Problem 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
Device Markings/Labelling Problem 1 1
Human-Device Interface Problem 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5583 5588
No Consequences Or Impact To Patient 1837 1837
No Patient Involvement 686 686
No Known Impact Or Consequence To Patient 506 506
Insufficient Information 407 407
Foreign Body In Patient 244 244
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
Unspecified Infection 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Tissue Damage 1 1
Paralysis 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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