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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device bit, drill
Product CodeHTW
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 1211 1211
2020 1245 1245
2021 1569 1569
2022 1519 1519
2023 1773 1773
2024 500 500

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4288 4288
Failure to Cut 979 979
Entrapment of Device 691 691
Material Deformation 584 584
Device-Device Incompatibility 564 564
Fracture 510 510
Material Twisted/Bent 337 337
Naturally Worn 242 242
Dull, Blunt 190 190
Mechanical Jam 89 89
Material Integrity Problem 79 79
Contamination /Decontamination Problem 63 63
Adverse Event Without Identified Device or Use Problem 49 49
No Apparent Adverse Event 42 42
Physical Resistance/Sticking 42 42
Material Fragmentation 39 39
Illegible Information 37 37
Detachment of Device or Device Component 34 34
Appropriate Term/Code Not Available 31 31
Corroded 27 27
Degraded 25 25
Scratched Material 20 20
Difficult to Remove 19 19
Improper or Incorrect Procedure or Method 17 17
Component Missing 15 15
Use of Device Problem 15 15
Material Separation 15 15
Device Contaminated During Manufacture or Shipping 15 15
Crack 14 14
Unintended Movement 13 13
Overheating of Device 12 12
Mechanical Problem 11 11
Packaging Problem 11 11
Structural Problem 10 10
Insufficient Information 10 10
Separation Failure 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Device Contamination with Chemical or Other Material 6 6
Difficult to Insert 6 6
Flaked 5 5
Delivered as Unsterile Product 5 5
Patient Device Interaction Problem 5 5
Material Split, Cut or Torn 4 4
Tear, Rip or Hole in Device Packaging 4 4
Smoking 4 4
Device Markings/Labelling Problem 4 4
Difficult to Advance 4 4
Failure to Align 4 4
Failure to Advance 3 3
Temperature Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Slipped 3 3
Product Quality Problem 3 3
Inaccurate Information 3 3
Device Handling Problem 3 3
Noise, Audible 3 3
Unclear Information 2 2
Activation, Positioning or Separation Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Melted 2 2
Nonstandard Device 2 2
Loss of or Failure to Bond 2 2
Material Disintegration 2 2
Device Difficult to Maintain 2 2
Expiration Date Error 2 2
Failure to Disconnect 2 2
Device Damaged by Another Device 2 2
Deformation Due to Compressive Stress 2 2
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1
Obstruction of Flow 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Positioning Problem 1 1
Compatibility Problem 1 1
Mechanics Altered 1 1
Positioning Failure 1 1
Complete Blockage 1 1
Optical Decentration 1 1
Material Frayed 1 1
Device, or device fragments remain in patient 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Inadequacy of Device Shape and/or Size 1 1
Unraveled Material 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1
Unexpected Color 1 1
Thickening of Material 1 1
Sharp Edges 1 1
Excessive Heating 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4474 4474
No Consequences Or Impact To Patient 1443 1443
Foreign Body In Patient 859 859
Insufficient Information 492 492
No Code Available 279 279
Device Embedded In Tissue or Plaque 182 182
No Known Impact Or Consequence To Patient 164 164
Not Applicable 114 114
No Patient Involvement 92 92
Injury 57 57
No Information 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Bone Fracture(s) 15 15
Unspecified Tissue Injury 13 13
Failure of Implant 12 12
Burn(s) 8 8
Hemorrhage/Bleeding 7 7
Pain 6 6
Unspecified Infection 6 6
Patient Problem/Medical Problem 6 6
Impaired Healing 3 3
Blood Loss 3 3
Tissue Damage 3 3
Perforation 3 3
Perforation of Vessels 2 2
Nerve Damage 2 2
Discomfort 2 2
Paralysis 2 2
Hypersensitivity/Allergic reaction 2 2
Laceration(s) 1 1
Necrosis 1 1
Death 1 1
Fever 1 1
Foreign Body Reaction 1 1
Hematoma 1 1
Vessel Or Plaque, Device Embedded In 1 1
Bacterial Infection 1 1
Deformity/ Disfigurement 1 1
Thromboembolism 1 1
Superficial (First Degree) Burn 1 1
Chills 1 1
Rupture 1 1
Pneumothorax 1 1
Loss of Range of Motion 1 1
Sepsis 1 1
Spinal Column Injury 1 1
Swelling 1 1
Full thickness (Third Degree) Burn 1 1
Vascular Dissection 1 1
Ischemia Stroke 1 1
Limb Fracture 1 1
Unspecified Musculoskeletal problem 1 1
Swelling/ Edema 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 Flower Orthopedics Corporation II Oct-14-2021
5 NEOSTEO II Aug-09-2021
6 Paragon 28, Inc. II Sep-17-2021
7 Trilliant Surgical, LLC II May-05-2020
8 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-06-2024
9 Zimmer GmbH II May-23-2019
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