• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1736 1736
2024 1152 1152

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3855 3855
Material Twisted/Bent 2465 2465
Device-Device Incompatibility 1419 1419
Fracture 808 808
Material Deformation 605 605
Naturally Worn 563 563
Calibration Problem 251 251
Material Integrity Problem 221 221
Contamination /Decontamination Problem 187 187
Entrapment of Device 122 122
Crack 95 95
Mechanical Jam 94 94
Mechanical Problem 87 87
Detachment of Device or Device Component 73 73
Compatibility Problem 69 69
Material Fragmentation 60 60
Connection Problem 55 55
Appropriate Term/Code Not Available 44 44
Use of Device Problem 43 43
Unintended Movement 38 38
Packaging Problem 34 34
Physical Resistance/Sticking 32 32
Component Missing 27 27
No Apparent Adverse Event 26 26
Adverse Event Without Identified Device or Use Problem 26 26
Defective Device 25 25
Device Slipped 22 22
Device Contamination with Chemical or Other Material 20 20
Delivered as Unsterile Product 19 19
Material Separation 17 22
Difficult to Remove 16 16
Scratched Material 16 16
Corroded 14 14
Illegible Information 14 14
Loose or Intermittent Connection 13 13
Dull, Blunt 10 10
Failure to Calibrate 9 9
Device Damaged Prior to Use 9 9
Device Difficult to Setup or Prepare 9 9
Electrical /Electronic Property Problem 8 8
Material Disintegration 7 7
Degraded 7 7
Fitting Problem 7 7
Noise, Audible 7 7
Structural Problem 7 7
Device Reprocessing Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Split, Cut or Torn 6 6
Device Difficult to Maintain 6 6
Improper or Incorrect Procedure or Method 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6208 6213
No Consequences Or Impact To Patient 1837 1837
No Patient Involvement 686 686
No Known Impact Or Consequence To Patient 506 506
Insufficient Information 491 491
Foreign Body In Patient 263 263
No Code Available 200 200
Device Embedded In Tissue or Plaque 94 94
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
Blood Loss 3 3
Perforation of Vessels 3 3
Skull Fracture 2 2
Bone Fracture(s) 2 2
Exsanguination 2 2
Perforation 2 2
Spinal Cord Injury 2 2
Impaired Healing 1 1
Unspecified Infection 1 1
Skin Inflammation/ Irritation 1 1
Ossification 1 1
Paralysis 1 1
Nerve Damage 1 1
Laceration(s) 1 1
Joint Laxity 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
5 Zimmer Biomet, Inc. II Jul-04-2019
-
-