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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
2017 1369 1369
2018 1468 1468
2019 2011 2011
2020 1644 1644
2021 2001 2001

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3590 3590
Material Twisted/Bent 1426 1426
Device-Device Incompatibility 756 756
Material Deformation 537 537
Fracture 530 530
Naturally Worn 439 439
Calibration Problem 218 218
Dull, Blunt 202 202
Appropriate Term/Code Not Available 176 176
Contamination /Decontamination Problem 129 129
Material Fragmentation 120 120
Material Integrity Problem 98 98
Crack 88 88
Mechanical Problem 77 77
Entrapment of Device 75 75
Device Contamination with Chemical or Other Material 72 72
Mechanical Jam 70 70
Connection Problem 63 63
Bent 61 61
Device Operates Differently Than Expected 52 52
Detachment of Device or Device Component 51 51
Peeled/Delaminated 39 39
Use of Device Problem 36 36
Packaging Problem 35 35
Compatibility Problem 34 34
Component Missing 32 32
Physical Resistance/Sticking 29 29
Difficult to Remove 28 28
Adverse Event Without Identified Device or Use Problem 25 25
Failure To Adhere Or Bond 24 24
Loose or Intermittent Connection 23 23
Detachment Of Device Component 21 21
Unintended Movement 21 21
Delivered as Unsterile Product 19 19
Fitting Problem 19 19
Defective Device 18 18
Device Slipped 17 17
Material Separation 14 14
Insufficient Information 14 14
Disassembly 13 13
Device Damaged Prior to Use 12 12
Corroded 10 10
Failure to Calibrate 9 9
Material Disintegration 8 8
Material Split, Cut or Torn 8 8
Device Difficult to Maintain 7 7
Material Distortion 7 7
Electrical /Electronic Property Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Defective Component 5 5
Device Reprocessing Problem 5 5
Noise, Audible 5 5
Separation Problem 5 5
Illegible Information 5 5
Incomplete or Inadequate Connection 4 4
No Apparent Adverse Event 4 4
Device Handling Problem 4 4
Scratched Material 4 4
Device Damaged by Another Device 4 4
Degraded 4 4
Unsealed Device Packaging 4 4
Sticking 4 4
Structural Problem 4 4
Failure to Align 4 4
Device Issue 3 3
Failure to Cut 3 3
Inadequacy of Device Shape and/or Size 3 3
Failure to Discharge 3 3
Material Discolored 3 3
Activation, Positioning or SeparationProblem 3 3
Device Markings/Labelling Problem 3 3
Mechanics Altered 3 3
Device Dislodged or Dislocated 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Device Sensing Problem 2 2
Device Operational Issue 2 2
Device Fell 2 2
Positioning Failure 2 2
Component Incompatible 2 2
Misassembled 2 2
Fluid Leak 2 2
Difficult to Insert 2 2
Microbial Contamination of Device 2 2
Device Inoperable 2 2
Unstable 2 2
Deformation Due to Compressive Stress 2 2
Dent in Material 2 2
Split 2 2
Failure to Disconnect 2 2
Separation Failure 2 2
Solder Joint Fracture 2 2
Loss of Osseointegration 1 1
Failure to Advance 1 1
Difficult or Delayed Activation 1 1
Defibrillation/Stimulation Problem 1 1
Material Too Rigid or Stiff 1 1
Metal Shedding Debris 1 1
Labelling, Instructions for Use or Training Problem 1 1
Kinked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2698 2698
No Clinical Signs, Symptoms or Conditions 2125 2125
No Known Impact Or Consequence To Patient 1512 1512
No Patient Involvement 1083 1083
No Information 360 360
No Code Available 353 353
Foreign Body In Patient 217 217
Not Applicable 191 191
Device Embedded In Tissue or Plaque 149 149
Insufficient Information 79 79
Injury 31 31
Patient Problem/Medical Problem 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Failure of Implant 11 11
Blood Loss 5 5
Unspecified Tissue Injury 4 4
Pain 3 3
Bone Fracture(s) 3 3
Sedation 3 3
Local Reaction 3 3
Skull Fracture 2 2
Exsanguination 2 2
Foreign Body Reaction 1 1
Dysphagia/ Odynophagia 1 1
Unspecified Infection 1 1
Irritation 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Spinal Cord Injury 1 1
Paralysis 1 1
Joint Laxity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Flower Orthopedics Corporation II Jun-01-2021
2 Synthes (USA) Products LLC II May-23-2018
3 Trilliant Surgical, LLC II Jan-10-2020
4 Zimmer Biomet, Inc. II Jul-04-2019
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