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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 540 540

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6721 6721
Material Twisted/Bent 2496 2496
Device-Device Incompatibility 1386 1386
Fracture 1101 1101
Material Deformation 810 810
Naturally Worn 714 714
Dull, Blunt 269 269
Material Fragmentation 267 267
Calibration Problem 249 249
Appropriate Term/Code Not Available 231 231
Material Integrity Problem 223 223
Device Operates Differently Than Expected 220 220
Contamination /Decontamination Problem 201 201
Crack 136 136
Entrapment of Device 127 127
Mechanical Problem 126 126
Mechanical Jam 123 123
Bent 107 107
Detachment of Device or Device Component 100 100
Detachment Of Device Component 90 90
Device Contamination with Chemical or Other Material 84 84
Compatibility Problem 70 70
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 37 37
Packaging Problem 35 35
Loose or Intermittent Connection 35 35
Physical Resistance/Sticking 34 34
Material Separation 27 32
Device Stops Intermittently 25 25
Defective Device 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
Improper or Incorrect Procedure or Method 11 11
Electrical /Electronic Property Problem 11 11
Illegible Information 11 11
Noise, Audible 10 10
Loss of Power 10 10
Failure to Calibrate 10 10
Structural Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Material Disintegration 9 9
Material Split, Cut or Torn 9 9
Device Handling Problem 9 9
Torn Material 9 9
Failure to Run on Battery 8 8
Positioning Problem 8 8
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
Activation, Positioning or Separation Problem 6 6
Failure to Align 6 6
Mechanics Altered 6 6
Device Dislodged or Dislocated 6 6
Device Damaged by Another Device 6 6
Residue After Decontamination 5 5
Device Issue 5 5
Failure to Disconnect 5 5
Shipping Damage or Problem 5 5
Device Remains Activated 5 5
Separation Problem 5 5
Incomplete or Inadequate Connection 4 4
Off-Label Use 4 4
Failure to Power Up 4 4
Nonstandard Device 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
Difficult to Advance 3 3
Failure to Cut 3 3
Failure to Discharge 3 3
Material Discolored 3 3
Failure To Run On AC/DC 3 3
Overheating of Device 3 3
Inadequacy of Device Shape and/or Size 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5676 5681
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 419 419
Device Embedded In Tissue or Plaque 354 354
Foreign Body In Patient 349 349
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
Reaction 2 2
Skull Fracture 2 2
Tissue Damage 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
Fracture, Arm 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Neck Pain 1 1
Test Result 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-23-2018
19 Trilliant Surgical, LLC II Jan-10-2020
20 Wright Medical Technology Inc II Sep-22-2010
21 Zimmer Biomet, Inc. II Jul-04-2019
22 Zimmer Inc. II Jul-06-2011
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