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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
2019 1955 1955
2020 1531 1531
2021 4802 4802
2022 3909 3909
2023 4405 4405
2024 410 410

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 11609 11609
Naturally Worn 1771 1771
Break 1519 1519
Dull, Blunt 1384 1384
Corroded 1215 1215
Material Twisted/Bent 699 699
Device-Device Incompatibility 529 529
Adverse Event Without Identified Device or Use Problem 436 436
Material Deformation 304 304
Entrapment of Device 298 298
Illegible Information 286 286
Crack 105 105
Contamination /Decontamination Problem 100 100
No Apparent Adverse Event 94 94
Scratched Material 63 63
Fracture 55 55
Mechanical Jam 53 53
Detachment of Device or Device Component 52 52
Device Contamination with Chemical or Other Material 46 46
Degraded 43 43
Material Discolored 40 40
Device Contaminated During Manufacture or Shipping 32 32
Material Integrity Problem 31 31
Loose or Intermittent Connection 24 24
Physical Resistance/Sticking 22 22
Component Missing 21 21
Unintended Movement 19 19
Improper or Incorrect Procedure or Method 14 14
Difficult to Insert 13 13
Appropriate Term/Code Not Available 12 12
Use of Device Problem 8 8
Product Quality Problem 7 7
Peeled/Delaminated 7 7
Difficult to Open or Close 6 6
Structural Problem 5 5
Material Fragmentation 5 5
Mechanical Problem 4 4
Difficult to Remove 4 4
Off-Label Use 4 4
Device Slipped 4 4
Device Damaged Prior to Use 4 4
Failure to Advance 4 4
Connection Problem 4 4
Failure to Clean Adequately 4 4
Positioning Failure 3 3
Loss of or Failure to Bond 2 2
Pitted 2 2
Delivered as Unsterile Product 2 2
Defective Component 2 2
Fitting Problem 2 2
Defective Device 2 2
Problem with Sterilization 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Positioning Problem 2 2
Incomplete or Inadequate Connection 1 1
Device Handling Problem 1 1
Insufficient Information 1 1
Device Difficult to Maintain 1 1
Packaging Problem 1 1
Measurement System Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Communication or Transmission Problem 1 1
Compatibility Problem 1 1
Device Tipped Over 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Particulates 1 1
Misassembled 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13169 13169
No Consequences Or Impact To Patient 2614 2614
Insufficient Information 545 545
No Code Available 405 405
Foreign Body In Patient 305 305
Not Applicable 151 151
No Patient Involvement 81 81
Bone Fracture(s) 48 48
Injury 31 31
No Known Impact Or Consequence To Patient 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Unspecified Infection 18 18
Unspecified Tissue Injury 16 16
Pain 11 11
Limb Fracture 10 10
Non-union Bone Fracture 9 9
Blood Loss 6 6
Failure of Implant 6 6
Septic Shock 5 5
Shock 4 4
Hemorrhage/Bleeding 4 4
Device Embedded In Tissue or Plaque 4 4
No Information 4 4
Low Blood Pressure/ Hypotension 3 3
Post Operative Wound Infection 3 3
Discomfort 2 2
Tissue Damage 2 2
Loss of Range of Motion 2 2
Hematoma 2 2
Laceration(s) 1 1
Nerve Damage 1 1
Neurological Deficit/Dysfunction 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Bradycardia 1 1
Burn(s) 1 1
Cyst(s) 1 1
Embolism 1 1
Fall 1 1
Foreign Body Reaction 1 1
Respiratory Distress 1 1
Physical Entrapment 1 1
Perforation of Vessels 1 1
Hip Fracture 1 1
Skin Tears 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Mar-01-2024
2 Synthes (USA) Products LLC II Dec-15-2020
3 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
4 Zimmer, Inc. II Feb-06-2023
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