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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device screwdriver
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 1644 1644
2021 2000 2000
2022 1721 1726
2023 1736 1736
2024 1715 1715
2025 315 315

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3558 3558
Material Twisted/Bent 2265 2265
Device-Device Incompatibility 1354 1354
Fracture 764 764
Material Deformation 478 478
Naturally Worn 427 427
Material Integrity Problem 233 233
Contamination /Decontamination Problem 149 149
Entrapment of Device 128 128
Calibration Problem 125 125
Mechanical Jam 83 83
Crack 77 77
Compatibility Problem 69 69
Mechanical Problem 66 66
Detachment of Device or Device Component 64 64
Connection Problem 53 53
Material Fragmentation 43 43
Appropriate Term/Code Not Available 38 38
Unintended Movement 30 30
Use of Device Problem 28 28
Defective Device 27 27
No Apparent Adverse Event 26 26
Material Separation 25 30
Device Slipped 24 24
Illegible Information 20 20
Physical Resistance/Sticking 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Material Discolored 15 15
Component Missing 14 14
Corroded 14 14
Scratched Material 14 14
Difficult to Remove 11 11
Degraded 9 9
Loose or Intermittent Connection 9 9
Device Difficult to Setup or Prepare 9 9
Electrical /Electronic Property Problem 9 9
Improper or Incorrect Procedure or Method 7 7
Noise, Audible 7 7
Mechanics Altered 7 7
Activation, Positioning or Separation Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Structural Problem 6 6
Off-Label Use 5 5
Packaging Problem 5 5
Device Reprocessing Problem 5 5
Dull, Blunt 4 4
Fitting Problem 4 4
Device Damaged by Another Device 4 4
Incomplete or Inadequate Connection 4 4
Failure to Cut 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6962 6967
No Consequences Or Impact To Patient 851 851
Insufficient Information 599 599
Foreign Body In Patient 234 234
No Patient Involvement 226 226
No Known Impact Or Consequence To Patient 205 205
No Code Available 112 112
Device Embedded In Tissue or Plaque 62 62
No Information 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Injury 16 16
Not Applicable 16 16
Unspecified Tissue Injury 10 10
Failure of Implant 9 9
Hemorrhage/Bleeding 5 5
Blood Loss 3 3
Exsanguination 2 2
Perforation 2 2
Bone Fracture(s) 2 2
Skull Fracture 2 2
Perforation of Vessels 2 2
Spinal Cord Injury 1 1
Laceration(s) 1 1
Joint Laxity 1 1
Ossification 1 1
Skin Inflammation/ Irritation 1 1
Pain 1 1
Non-union Bone Fracture 1 1
Unspecified Infection 1 1
Tissue Damage 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-28-2024
4 Trilliant Surgical, LLC II Jan-10-2020
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