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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reamer
Regulation Description Orthopedic manual surgical instrument.
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 4804 4804

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 4669 4669
Dull, Blunt 2917 2917
Break 1248 1248
Corroded 1162 1162
Naturally Worn 789 789
Material Twisted/Bent 703 703
Adverse Event Without Identified Device or Use Problem 370 370
Device-Device Incompatibility 304 304
Material Deformation 270 270
Illegible Information 218 218
Appropriate Term/Code Not Available 191 191
Crack 167 167
Entrapment of Device 158 158
Material Discolored 116 116
Fracture 73 73
Scratched Material 71 71
Contamination /Decontamination Problem 64 64
Detachment of Device or Device Component 48 48
Pitted 47 47
Device Contamination with Chemical or Other Material 47 47
Mechanical Jam 46 46
Loose or Intermittent Connection 44 44
Material Fragmentation 43 43
Component Missing 27 27
Degraded 23 23
Physical Resistance/Sticking 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
Material Integrity Problem 15 15
Disassembly 13 13
Mechanical Problem 11 11
Insufficient Information 11 11
Difficult to Remove 9 9
No Apparent Adverse Event 8 8
Peeled/Delaminated 7 7
Device Disinfection Or Sterilization Issue 7 7
Product Quality Problem 7 7
Use of Device Problem 6 6
Device Slipped 6 6
Detachment Of Device Component 6 6
Unintended Movement 6 6
Failure to Clean Adequately 5 5
Difficult to Open or Close 5 5
Improper or Incorrect Procedure or Method 5 5
Fitting Problem 5 5
Device Damaged Prior to Use 4 4
Failure to Advance 4 4
Patient-Device Incompatibility 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
Defective Component 3 3
Positioning Problem 3 3
Packaging Problem 2 2
Device Difficult to Maintain 2 2
Material Split, Cut or Torn 2 2
Device Dislodged or Dislocated 2 2
Material Distortion 2 2
Problem with Sterilization 2 2
Failure to Align 2 2
Inadequacy of Device Shape and/or Size 2 2
Off-Label Use 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
Difficult To Position 1 1
Difficult or Delayed Positioning 1 1
Component Falling 1 1
Cut In Material 1 1
Structural Problem 1 1
Metal Shedding Debris 1 1
Device Issue 1 1
Overfill 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Microbial Contamination of Device 1 1
Battery Problem 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
Device Markings/Labelling Problem 1 1
Communication or Transmission Problem 1 1
Difficult to Advance 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Electrical Power Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Measurement System Incompatibility 1 1
Optical Discoloration 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4866 4866
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 287 287
Not Applicable 218 218
Foreign Body In Patient 212 212
No Patient Involvement 157 157
Bone Fracture(s) 60 60
Device Embedded In Tissue or Plaque 32 32
Injury 31 31
Pain 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Unspecified Infection 19 19
Blood Loss 19 19
Non-union Bone Fracture 10 10
Failure of Implant 5 5
Low Blood Pressure/ Hypotension 3 3
Limb Fracture 3 3
Patient Problem/Medical Problem 2 2
Impaired Healing 2 2
Hip Fracture 2 2
Sedation 2 2
Embolism 2 2
Tissue Damage 2 2
Nerve Damage 1 1
Neurological Deficit/Dysfunction 1 1
Loss of Range of Motion 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Bradycardia 1 1
Death 1 1
Physical Entrapment 1 1
Discomfort 1 1
Joint Disorder 1 1
Alteration In Body Temperature 1 1
Unspecified Tissue Injury 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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