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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bit, drill
Product CodeHTW
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 1129 1129
2018 1241 1241
2019 1211 1211
2020 1244 1244
2021 1577 1577
2022 504 504

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3843 3843
Failure to Cut 562 562
Fracture 468 468
Entrapment of Device 432 432
Material Twisted/Bent 417 417
Device-Device Incompatibility 354 354
Material Deformation 352 352
Dull, Blunt 324 324
Bent 174 174
Material Fragmentation 140 140
Naturally Worn 113 113
Mechanical Jam 72 72
Device Operates Differently Than Expected 71 71
Appropriate Term/Code Not Available 68 68
Corroded 59 59
Adverse Event Without Identified Device or Use Problem 49 49
Detachment of Device or Device Component 42 42
Insufficient Information 35 35
Detachment Of Device Component 35 35
Physical Resistance/Sticking 32 32
Contamination /Decontamination Problem 32 32
Illegible Information 31 31
Crack 31 31
Difficult to Remove 29 29
Component Missing 28 28
Material Integrity Problem 26 26
Mechanical Problem 23 23
Use of Device Problem 22 22
Packaging Problem 20 20
Delivered as Unsterile Product 18 18
Failure to Align 17 17
Scratched Material 17 17
Improper or Incorrect Procedure or Method 16 16
Degraded 16 16
Separation Failure 15 15
Device Contaminated During Manufacture or Shipping 14 14
Unintended Movement 13 13
Device Contamination with Chemical or Other Material 12 12
Material Separation 12 12
Overheating of Device 10 10
Incorrect Measurement 9 9
Tear, Rip or Hole in Device Packaging 8 8
Structural Problem 7 7
Difficult to Insert 7 7
Defective Device 6 6
Connection Problem 6 6
Device Markings/Labelling Problem 5 5
Temperature Problem 5 5
Flaked 5 5
Product Quality Problem 5 5
Nonstandard Device 4 4
Loose or Intermittent Connection 4 4
Residue After Decontamination 4 4
Fitting Problem 4 4
Device Handling Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
No Apparent Adverse Event 4 4
Device Fell 3 3
Device Packaging Compromised 3 3
Device Difficult to Maintain 3 3
Mechanics Altered 3 3
Device Slipped 3 3
Unraveled Material 3 3
Device Issue 3 3
Loss of or Failure to Bond 3 3
Component Falling 3 3
Material Disintegration 2 2
Difficult or Delayed Positioning 2 2
Failure to Advance 2 2
Expiration Date Error 2 2
Patient-Device Incompatibility 2 2
Failure to Disconnect 2 2
Unstable 2 2
Device Inoperable 2 2
Metal Shedding Debris 2 2
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Deformation Due to Compressive Stress 2 2
Device Operational Issue 2 2
Difficult to Advance 2 2
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Device Damaged by Another Device 1 1
Activation, Positioning or SeparationProblem 1 1
Torn Material 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Material Split, Cut or Torn 1 1
Excessive Heating 1 1
Difficult or Delayed Separation 1 1
Inaccurate Information 1 1
Vibration 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1
Smoking 1 1
Sticking 1 1
Shelf Life Exceeded 1 1
Inadequacy of Device Shape and/or Size 1 1
Battery Problem 1 1
Device Or Device Fragments Location Unknown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2316 2316
No Clinical Signs, Symptoms or Conditions 1825 1825
Foreign Body In Patient 755 755
No Known Impact Or Consequence To Patient 633 633
No Information 453 453
No Code Available 380 380
Device Embedded In Tissue or Plaque 316 316
No Patient Involvement 251 251
Not Applicable 166 166
Insufficient Information 142 142
Injury 69 69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Bone Fracture(s) 15 15
Failure of Implant 12 12
Burn(s) 10 10
Pain 8 8
Patient Problem/Medical Problem 7 7
Unspecified Tissue Injury 7 7
Tissue Damage 6 6
Hemorrhage/Bleeding 6 6
Unspecified Infection 5 5
Hematoma 4 4
Paralysis 3 3
Laceration(s) 3 3
Impaired Healing 3 3
Blood Loss 3 3
Perforation of Vessels 2 2
Discomfort 2 2
Swelling 2 2
Synovitis 1 1
Nerve Damage 1 1
Pneumothorax 1 1
Loss of Range of Motion 1 1
Spinal Column Injury 1 1
Death 1 1
Fever 1 1
Infiltration into Tissue 1 1
Vessel Or Plaque, Device Embedded In 1 1
Chills 1 1
Burn, Thermal 1 1
Hip Fracture 1 1
Deformity/ Disfigurement 1 1
Thromboembolism 1 1
Ischemia Stroke 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag III Dec-22-2019
2 Arthrex, Inc. II Mar-26-2021
3 Biomet, Inc. II Dec-17-2020
4 Cayenne Medical Inc. II Jul-28-2018
5 Flower Orthopedics Corporation II Oct-14-2021
6 MicroAire Surgical Instruments, LLC II Jan-26-2018
7 NEOSTEO II Aug-09-2021
8 Paragon 28, Inc. II Sep-17-2021
9 Tornier, Inc II May-09-2018
10 Trilliant Surgical, LLC II May-05-2020
11 Zimmer GmbH II May-23-2019
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