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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reamer
Product CodeHTO
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 1234 1234
2018 1835 1835
2019 1954 1954
2020 1531 1531
2021 4805 4805
2022 3161 3161

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 7249 7249
Dull, Blunt 2922 2922
Break 1499 1499
Corroded 1209 1209
Naturally Worn 964 964
Material Twisted/Bent 703 703
Adverse Event Without Identified Device or Use Problem 462 462
Device-Device Incompatibility 380 380
Material Deformation 291 291
Illegible Information 236 236
Entrapment of Device 227 227
Appropriate Term/Code Not Available 192 192
Crack 183 183
Material Discolored 116 116
Fracture 89 89
Contamination /Decontamination Problem 83 83
Scratched Material 72 72
Mechanical Jam 52 52
Detachment of Device or Device Component 52 52
No Apparent Adverse Event 51 51
Device Contamination with Chemical or Other Material 47 47
Pitted 47 47
Material Fragmentation 44 44
Loose or Intermittent Connection 44 44
Degraded 30 30
Component Missing 27 27
Physical Resistance/Sticking 23 23
Material Integrity Problem 22 22
Difficult to Insert 19 19
Connection Problem 18 18
Device Operates Differently Than Expected 16 16
Bent 16 16
Material Erosion 15 15
Disassembly 13 13
Unintended Movement 12 12
Insufficient Information 11 11
Mechanical Problem 11 11
Difficult to Remove 9 9
Product Quality Problem 8 8
Use of Device Problem 8 8
Device Disinfection Or Sterilization Issue 7 7
Peeled/Delaminated 7 7
Detachment Of Device Component 6 6
Device Slipped 6 6
Difficult to Open or Close 6 6
Failure to Clean Adequately 5 5
Improper or Incorrect Procedure or Method 5 5
Fitting Problem 5 5
Device Damaged Prior to Use 4 4
Patient-Device Incompatibility 4 4
Failure to Advance 4 4
Failure To Adhere Or Bond 4 4
Positioning Failure 4 4
Device Reprocessing Problem 4 4
Loss of or Failure to Bond 3 3
Off-Label Use 3 3
Structural Problem 3 3
Defective Component 3 3
Positioning Problem 3 3
Packaging Problem 2 2
Device Difficult to Maintain 2 2
Device Dislodged or Dislocated 2 2
Material Distortion 2 2
Material Split, Cut or Torn 2 2
Problem with Sterilization 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Align 2 2
Delivered as Unsterile Product 2 2
Particulates 1 1
Hole In Material 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Misconnection 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Difficult To Position 1 1
Difficult or Delayed Positioning 1 1
Component Falling 1 1
Dent in Material 1 1
Separation Failure 1 1
Defective Device 1 1
Device Tipped Over 1 1
Device Or Device Fragments Location Unknown 1 1
Battery Problem 1 1
Communication or Transmission Problem 1 1
Device Markings/Labelling Problem 1 1
Metal Shedding Debris 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
Overfill 1 1
Cut In Material 1 1
Measurement System Incompatibility 1 1
Optical Discoloration 1 1
Output below Specifications 1 1
Electrical Power Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Open or Remove Packaging Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7923 7923
No Consequences Or Impact To Patient 4750 4750
No Information 619 619
No Code Available 483 483
No Known Impact Or Consequence To Patient 390 390
Insufficient Information 308 308
Foreign Body In Patient 282 282
Not Applicable 218 218
No Patient Involvement 157 157
Bone Fracture(s) 64 64
Device Embedded In Tissue or Plaque 32 32
Pain 31 31
Injury 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Unspecified Infection 21 21
Blood Loss 19 19
Non-union Bone Fracture 11 11
Unspecified Tissue Injury 8 8
Limb Fracture 7 7
Failure of Implant 6 6
Septic Shock 5 5
Shock 4 4
Low Blood Pressure/ Hypotension 3 3
Hemorrhage/Bleeding 2 2
Loss of Range of Motion 2 2
Embolism 2 2
Tissue Damage 2 2
Nerve Damage 2 2
Discomfort 2 2
Hip Fracture 2 2
Sedation 2 2
Impaired Healing 2 2
Patient Problem/Medical Problem 2 2
Unspecified Nervous System Problem 1 1
Skin Tears 1 1
Alteration In Body Temperature 1 1
Joint Disorder 1 1
Physical Entrapment 1 1
Neurological Deficit/Dysfunction 1 1
Fall 1 1
Hematoma 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Bradycardia 1 1
Death 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-09-2018
2 Cayenne Medical Inc. II Jul-25-2018
3 Encore Medical, Lp II Aug-31-2017
4 Synthes (USA) Products LLC II Dec-15-2020
5 Synthes (USA) Products LLC II Mar-05-2018
6 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
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