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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
2016 990 990
2017 1369 1369
2018 1468 1468
2019 2011 2011
2020 1643 1643
2021 662 662

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3733 3733
Material Twisted/Bent 1165 1165
Fracture 541 541
Device-Device Incompatibility 518 518
Material Deformation 496 496
Naturally Worn 357 357
Dull, Blunt 240 240
Calibration Problem 208 208
Appropriate Term/Code Not Available 202 202
Material Fragmentation 201 201
Device Operates Differently Than Expected 98 98
Contamination /Decontamination Problem 97 97
Crack 88 88
Bent 87 87
Device Contamination with Chemical or Other Material 72 72
Mechanical Problem 63 63
Mechanical Jam 63 63
Material Integrity Problem 62 62
Connection Problem 60 60
Entrapment of Device 57 57
Peeled/Delaminated 41 41
Detachment Of Device Component 41 41
Detachment of Device or Device Component 38 38
Component Missing 38 38
Failure To Adhere Or Bond 36 36
Packaging Problem 35 35
Difficult to Remove 32 32
Use of Device Problem 30 30
Fitting Problem 29 29
Loose or Intermittent Connection 27 27
Physical Resistance/Sticking 27 27
Adverse Event Without Identified Device or Use Problem 23 23
Device Slipped 20 20
Unintended Movement 19 19
Delivered as Unsterile Product 19 19
Defective Device 17 17
Material Separation 16 16
Insufficient Information 16 16
Disassembly 15 15
Material Distortion 15 15
Compatibility Problem 14 14
Device Damaged Prior to Use 12 12
Failure to Calibrate 10 10
Material Disintegration 8 8
Material Split, Cut or Torn 8 8
Sticking 7 7
Device Inoperable 7 7
Device Difficult to Maintain 7 7
Corroded 6 6
Device Reprocessing Problem 6 6
Separation Problem 5 5
Noise, Audible 5 5
Electrical /Electronic Property Problem 5 5
Defective Component 5 5
Improper or Incorrect Procedure or Method 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Handling Problem 4 4
Illegible Information 4 4
Device Damaged by Another Device 4 4
Unsealed Device Packaging 4 4
Structural Problem 4 4
Failure to Align 4 4
Device Issue 4 4
Device Dislodged or Dislocated 3 3
Deformation Due to Compressive Stress 3 3
No Apparent Adverse Event 3 3
Failure to Disconnect 3 3
Scratched Material 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Discolored 3 3
Calibration Error 2 2
Component Falling 2 2
Output above Specifications 2 2
Misassembled 2 2
Difficult to Insert 2 2
Unstable 2 2
Dent in Material 2 2
Device Markings/Labelling Problem 2 2
Device Sensing Problem 2 2
Device Fell 2 2
Mechanics Altered 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Activation, Positioning or SeparationProblem 2 2
Device Operational Issue 2 2
Microbial Contamination of Device 2 2
Failure to Cut 2 2
Split 2 2
Component Incompatible 2 2
Nonstandard Device 2 2
Fluid Leak 2 2
Degraded 2 2
Positioning Failure 2 2
Complete Blockage 1 1
Loss of or Failure to Bond 1 1
Material Too Rigid or Stiff 1 1
Separation Failure 1 1
Metal Shedding Debris 1 1
Device Or Device Fragments Location Unknown 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2731 2731
No Known Impact Or Consequence To Patient 2152 2152
No Patient Involvement 1200 1200
No Clinical Signs, Symptoms or Conditions 850 850
No Information 479 479
No Code Available 383 383
Foreign Body In Patient 209 209
Not Applicable 192 192
Device Embedded In Tissue or Plaque 189 189
Injury 32 32
Insufficient Information 32 32
Patient Problem/Medical Problem 19 19
Failure of Implant 10 10
Sedation 6 6
Blood Loss 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Local Reaction 3 3
Bone Fracture(s) 3 3
Pain 3 3
Unspecified Infection 2 2
Unspecified Tissue Injury 2 2
Exsanguination 2 2
Dysphagia/ Odynophagia 1 1
Irritation 1 1
Perforation of Vessels 1 1
Spinal Cord Injury 1 1
Joint Laxity 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Paralysis 1 1
Death 1 1
Foreign Body Reaction 1 1
Tissue Damage 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Greatbatch Medical II Jun-01-2016
2 Orthofix, Inc II Jun-01-2016
3 Synthes (USA) Products LLC II May-23-2018
4 Trilliant Surgical, LLC II Jan-10-2020
5 Zimmer Biomet, Inc. II Jul-04-2019
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