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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
2018 1835 1835
2019 1954 1954
2020 1531 1531
2021 4805 4805
2022 3926 3926
2023 1405 1405

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 8889 8889
Dull, Blunt 2325 2325
Break 1527 1527
Corroded 1140 1140
Naturally Worn 1085 1085
Material Twisted/Bent 705 705
Adverse Event Without Identified Device or Use Problem 480 480
Device-Device Incompatibility 460 460
Material Deformation 318 318
Illegible Information 278 278
Entrapment of Device 254 254
Crack 168 168
Appropriate Term/Code Not Available 104 104
Material Discolored 95 95
Fracture 91 91
Contamination /Decontamination Problem 90 90
No Apparent Adverse Event 89 89
Scratched Material 66 66
Mechanical Jam 58 58
Detachment of Device or Device Component 50 50
Device Contamination with Chemical or Other Material 47 47
Loose or Intermittent Connection 41 41
Pitted 38 38
Degraded 31 31
Device Contaminated During Manufacture or Shipping 30 30
Material Integrity Problem 25 25
Physical Resistance/Sticking 23 23
Component Missing 21 21
Difficult to Insert 19 19
Material Erosion 15 15
Unintended Movement 14 14
Material Fragmentation 13 13
Improper or Incorrect Procedure or Method 12 12
Connection Problem 11 11
Product Quality Problem 9 9
Mechanical Problem 9 9
Device Slipped 8 8
Peeled/Delaminated 7 7
Device Disinfection Or Sterilization Issue 7 7
Use of Device Problem 7 7
Difficult to Open or Close 6 6
Difficult to Remove 6 6
Device Operates Differently Than Expected 5 5
Failure to Clean Adequately 5 5
Insufficient Information 4 4
Device Damaged Prior to Use 4 4
Patient-Device Incompatibility 4 4
Failure to Advance 4 4
Off-Label Use 4 4
Positioning Failure 4 4
Bent 4 4
Detachment Of Device Component 3 3
Defective Component 3 3
Structural Problem 3 3
Positioning Problem 3 3
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Device Difficult to Maintain 2 2
Packaging Problem 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Loss of or Failure to Bond 2 2
Delivered as Unsterile Product 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Problem with Sterilization 2 2
Fitting Problem 2 2
Device Stops Intermittently 1 1
Particulates 1 1
Material Puncture/Hole 1 1
Difficult To Position 1 1
Difficult or Delayed Positioning 1 1
Misassembled 1 1
Hole In Material 1 1
Compatibility Problem 1 1
Measurement System Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Power Problem 1 1
Difficult to Advance 1 1
Device Tipped Over 1 1
Dent in Material 1 1
Separation Failure 1 1
Battery Problem 1 1
Communication or Transmission Problem 1 1
Cut In Material 1 1
Device Issue 1 1
Overfill 1 1
Optical Discoloration 1 1
Output below Specifications 1 1
Device Handling Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Separation Problem 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9971 9971
No Consequences Or Impact To Patient 4137 4137
No Code Available 459 459
Insufficient Information 393 393
Foreign Body In Patient 304 304
Not Applicable 217 217
No Known Impact Or Consequence To Patient 120 120
No Patient Involvement 115 115
Bone Fracture(s) 63 63
Pain 32 32
Injury 31 31
No Information 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Unspecified Infection 19 19
Blood Loss 18 18
Device Embedded In Tissue or Plaque 13 13
Unspecified Tissue Injury 12 12
Non-union Bone Fracture 11 11
Limb Fracture 8 8
Failure of Implant 6 6
Septic Shock 5 5
Shock 4 4
Low Blood Pressure/ Hypotension 3 3
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Embolism 2 2
Loss of Range of Motion 2 2
Nerve Damage 2 2
Discomfort 2 2
Patient Problem/Medical Problem 2 2
Unspecified Nervous System Problem 1 1
Joint Disorder 1 1
Skin Tears 1 1
Hip Fracture 1 1
Physical Entrapment 1 1
Neurological Deficit/Dysfunction 1 1
Laceration(s) 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Fall 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Bradycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-09-2018
2 Cayenne Medical Inc. II Jul-25-2018
3 Synthes (USA) Products LLC II Dec-15-2020
4 Synthes (USA) Products LLC II Mar-05-2018
5 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
6 Zimmer, Inc. II Feb-06-2023
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