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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
2014 793 793
2015 881 881
2016 990 990
2017 1369 1369
2018 1468 1468
2019 2011 2011
2020 1644 1644
2021 2000 2000
2022 1721 1726
2023 1736 1736
2024 715 715

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6790 6790
Material Twisted/Bent 2542 2542
Device-Device Incompatibility 1414 1414
Fracture 1124 1124
Material Deformation 827 827
Naturally Worn 716 716
Dull, Blunt 269 269
Material Fragmentation 267 267
Calibration Problem 249 249
Appropriate Term/Code Not Available 241 241
Material Integrity Problem 225 225
Device Operates Differently Than Expected 220 220
Contamination /Decontamination Problem 203 203
Crack 138 138
Entrapment of Device 128 128
Mechanical Problem 126 126
Mechanical Jam 126 126
Bent 107 107
Detachment of Device or Device Component 102 102
Detachment Of Device Component 90 90
Device Contamination with Chemical or Other Material 84 84
Compatibility Problem 71 71
Connection Problem 66 66
Failure To Adhere Or Bond 64 64
Difficult to Remove 54 54
Device Slipped 52 52
Component Missing 51 51
Use of Device Problem 49 49
Fitting Problem 46 46
Peeled/Delaminated 45 45
Adverse Event Without Identified Device or Use Problem 41 41
Unintended Movement 39 39
Packaging Problem 35 35
Loose or Intermittent Connection 35 35
Physical Resistance/Sticking 34 34
Defective Device 31 31
Material Separation 27 32
Device Stops Intermittently 25 25
Sticking 24 24
Material Distortion 23 23
Failure to Shut Off 21 21
No Apparent Adverse Event 21 21
Device Inoperable 20 20
Continuous Firing 20 20
Delivered as Unsterile Product 19 19
Insufficient Information 19 19
Corroded 18 18
Device Or Device Fragments Location Unknown 18 18
Device Damaged Prior to Use 17 17
Disassembly 16 16
Scratched Material 15 15
Illegible Information 12 12
Electrical /Electronic Property Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Failure to Calibrate 10 10
Structural Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Loss of Power 10 10
Noise, Audible 10 10
Torn Material 9 9
Material Split, Cut or Torn 9 9
Device Handling Problem 9 9
Material Disintegration 9 9
Failure to Run on Battery 8 8
Positioning Problem 8 8
Mechanics Altered 7 7
Defective Component 7 7
Separation Failure 7 7
Degraded 7 7
Device Reprocessing Problem 7 7
Device Difficult to Maintain 7 7
Component Falling 6 6
Failure to Align 6 6
Device Dislodged or Dislocated 6 6
Activation, Positioning or Separation Problem 6 6
Device Damaged by Another Device 6 6
Residue After Decontamination 5 5
Device Issue 5 5
Failure to Disconnect 5 5
Material Discolored 5 5
Nonstandard Device 5 5
Device Remains Activated 5 5
Shipping Damage or Problem 5 5
Separation Problem 5 5
Incomplete or Inadequate Connection 4 4
Failure to Power Up 4 4
Off-Label Use 4 4
Unsealed Device Packaging 4 4
Difficult to Insert 4 4
Deformation Due to Compressive Stress 4 4
Device Operational Issue 4 4
Device Markings/Labelling Problem 4 4
Power Problem 4 4
Material Torqued 3 3
Output Problem 3 3
Difficult to Advance 3 3
Failure to Cut 3 3
Inadequacy of Device Shape and/or Size 3 3
Failure to Discharge 3 3
Failure To Run On AC/DC 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5829 5834
No Consequences Or Impact To Patient 3045 3045
No Known Impact Or Consequence To Patient 2963 2963
No Patient Involvement 1437 1437
No Information 548 548
No Code Available 456 456
Insufficient Information 439 439
Device Embedded In Tissue or Plaque 354 354
Foreign Body In Patient 353 353
Not Applicable 192 192
Sedation 53 53
Injury 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Patient Problem/Medical Problem 19 19
Failure of Implant 15 15
Blood Loss 9 9
Unspecified Tissue Injury 9 9
Pain 6 6
Hemorrhage/Bleeding 6 6
Bone Fracture(s) 4 4
Laceration(s) 4 4
Unspecified Infection 4 4
Spinal Cord Injury 3 3
Local Reaction 3 3
Perforation of Vessels 3 3
Perforation 2 2
Skull Fracture 2 2
Tissue Damage 2 2
Reaction 2 2
Exsanguination 2 2
Fall 1 1
Foreign Body Reaction 1 1
Ossification 1 1
Arthritis 1 1
Erosion 1 1
Burn(s) 1 1
Death 1 1
Dysphagia/ Odynophagia 1 1
Emotional Changes 1 1
Infiltration into Tissue 1 1
Irritation 1 1
Nerve Damage 1 1
Paralysis 1 1
Neck Pain 1 1
Test Result 1 1
Fracture, Arm 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Missing Value Reason 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 Ascension Orthopedics, Inc II Jun-26-2009
3 Biomet, Inc. II Sep-28-2012
4 Ebi, Llc II Jun-17-2014
5 Ebi, Llc II Nov-27-2013
6 Ebi, Llc II Mar-15-2013
7 Ebi, Llc II Dec-17-2012
8 Flower Orthopedics Corporation II Jun-01-2021
9 Greatbatch Medical II Jun-01-2016
10 Interventional Spine Inc II Oct-13-2011
11 Medtronic Sofamor Danek USA Inc II Jan-30-2014
12 Medtronic Sofamor Danek USA Inc II Sep-14-2013
13 Orthofix, Inc II Jun-01-2016
14 SpineFrontier, Inc. II Aug-13-2013
15 SpineFrontier, Inc. II Aug-08-2013
16 SpineFrontier, Inc. II Aug-08-2013
17 SpineFrontier, Inc. II Jul-05-2013
18 Synthes (USA) Products LLC II May-28-2024
19 Synthes (USA) Products LLC II May-23-2018
20 Trilliant Surgical, LLC II Jan-10-2020
21 Wright Medical Technology Inc II Sep-22-2010
22 Zimmer Biomet, Inc. II Jul-04-2019
23 Zimmer Inc. II Jul-06-2011
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