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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 1270 1270

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4216 4216
Failure to Cut 692 692
Fracture 507 507
Entrapment of Device 506 506
Material Deformation 433 433
Material Twisted/Bent 420 420
Device-Device Incompatibility 404 404
Dull, Blunt 330 330
Bent 174 174
Material Fragmentation 143 143
Naturally Worn 128 128
Mechanical Jam 81 81
Appropriate Term/Code Not Available 76 76
Device Operates Differently Than Expected 71 71
Corroded 69 69
Adverse Event Without Identified Device or Use Problem 53 53
Material Integrity Problem 48 48
Detachment of Device or Device Component 44 44
Contamination /Decontamination Problem 43 43
Insufficient Information 36 36
Physical Resistance/Sticking 35 35
Detachment Of Device Component 35 35
Crack 32 32
Illegible Information 32 32
Difficult to Remove 29 29
Component Missing 28 28
Use of Device Problem 26 26
Mechanical Problem 23 23
Packaging Problem 21 21
Degraded 20 20
Delivered as Unsterile Product 18 18
Improper or Incorrect Procedure or Method 18 18
Failure to Align 17 17
Scratched Material 17 17
Separation Failure 16 16
Device Contaminated During Manufacture or Shipping 14 14
Unintended Movement 13 13
Material Separation 13 13
Device Contamination with Chemical or Other Material 12 12
Overheating of Device 10 10
Incorrect Measurement 9 9
No Apparent Adverse Event 9 9
Tear, Rip or Hole in Device Packaging 8 8
Structural Problem 8 8
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
Device Packaging Compromised 3 3
Device Difficult to Maintain 3 3
Mechanics Altered 3 3
Therapeutic or Diagnostic Output Failure 3 3
Inaccurate Information 3 3
Device Fell 3 3
Device Slipped 3 3
Unraveled Material 3 3
Device Issue 3 3
Labelling, Instructions for Use or Training Problem 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
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 Separation Problem 1 1
Material Split, Cut or Torn 1 1
Torn Material 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Excessive Heating 1 1
Difficult or Delayed Separation 1 1
Thickening of Material 1 1
Sharp Edges 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2478 2478
No Consequences Or Impact To Patient 2316 2316
Foreign Body In Patient 833 833
No Known Impact Or Consequence To Patient 633 633
No Information 453 453
No Code Available 380 380
Device Embedded In Tissue or Plaque 331 331
No Patient Involvement 251 251
Insufficient Information 167 167
Not Applicable 166 166
Injury 69 69
Bone Fracture(s) 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Failure of Implant 13 13
Unspecified Tissue Injury 11 11
Burn(s) 10 10
Pain 9 9
Patient Problem/Medical Problem 7 7
Tissue Damage 6 6
Unspecified Infection 6 6
Hemorrhage/Bleeding 6 6
Hematoma 4 4
Laceration(s) 3 3
Paralysis 3 3
Impaired Healing 3 3
Blood Loss 3 3
Perforation of Vessels 2 2
Swelling 2 2
Nerve Damage 2 2
Discomfort 2 2
Rupture 1 1
Synovitis 1 1
Chills 1 1
Burn, Thermal 1 1
Hip Fracture 1 1
Deformity/ Disfigurement 1 1
Thromboembolism 1 1
Pneumothorax 1 1
Loss of Range of Motion 1 1
Sepsis 1 1
Spinal Column Injury 1 1
Necrosis 1 1
Infiltration into Tissue 1 1
Hypersensitivity/Allergic reaction 1 1
Death 1 1
Fever 1 1
Vessel Or Plaque, Device Embedded In 1 1
Bacterial Infection 1 1
Swelling/ Edema 1 1
Vascular Dissection 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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