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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device template
Product CodeHWT
Regulation Number 888.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 651 651
2018 713 713
2019 741 741
2020 938 938
2021 2182 2182
2022 1781 1781

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3221 3221
Naturally Worn 751 751
Device-Device Incompatibility 698 698
Crack 500 500
Scratched Material 443 443
Material Twisted/Bent 398 398
Fracture 361 361
Detachment of Device or Device Component 310 310
Material Deformation 248 248
Contamination /Decontamination Problem 207 207
Illegible Information 164 164
Material Integrity Problem 143 143
Component Missing 126 126
Appropriate Term/Code Not Available 113 113
Mechanical Jam 100 100
Adverse Event Without Identified Device or Use Problem 78 78
Insufficient Information 66 66
Use of Device Problem 54 54
Entrapment of Device 44 44
Unintended Movement 44 44
Physical Resistance/Sticking 40 40
Failure to Cut 38 38
Material Discolored 35 35
Incorrect Measurement 32 32
Peeled/Delaminated 32 32
Loose or Intermittent Connection 29 29
Mechanical Problem 22 22
Corroded 22 22
Device Contamination With Biological Material 22 22
Device Dislodged or Dislocated 21 21
Dull, Blunt 21 21
No Apparent Adverse Event 20 20
Disassembly 19 19
Difficult to Remove 19 19
Connection Problem 18 18
Structural Problem 15 15
Bent 14 14
Material Fragmentation 13 13
Device Operates Differently Than Expected 13 13
Compatibility Problem 11 11
Difficult to Insert 10 10
Separation Failure 7 7
Fitting Problem 7 7
Loss of Osseointegration 7 7
Device Operational Issue 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Slipped 6 6
Off-Label Use 6 6
Separation Problem 6 6
Difficult to Open or Close 5 5
Defective Device 5 5
Device Issue 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Markings/Labelling Problem 4 4
Loss of or Failure to Bond 4 4
Migration 4 4
Positioning Problem 4 4
Material Split, Cut or Torn 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Degraded 3 3
Improper or Incorrect Procedure or Method 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Damaged Prior to Use 3 3
Defective Component 2 2
Tear, Rip or Hole in Device Packaging 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Device Damaged by Another Device 2 2
Pitted 2 2
Detachment Of Device Component 2 2
Material Disintegration 2 2
Patient Device Interaction Problem 2 2
Incomplete or Inadequate Connection 2 2
Material Distortion 2 2
Device Handling Problem 2 2
Noise, Audible 1 1
Misassembly by Users 1 1
Device Difficult to Maintain 1 1
Mechanics Altered 1 1
Protective Measures Problem 1 1
Packaging Problem 1 1
Difficult or Delayed Separation 1 1
Inaccurate Information 1 1
Display Difficult to Read 1 1
Device Expiration Issue 1 1
Flaked 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Metal Shedding Debris 1 1
Unstable 1 1
Material Separation 1 1
Difficult to Advance 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Lack of Maintenance Documentation or Guidelines 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 3932 3932
No Consequences Or Impact To Patient 1871 1871
No Information 428 428
No Known Impact Or Consequence To Patient 289 289
No Code Available 150 150
No Patient Involvement 135 135
Insufficient Information 123 123
Not Applicable 86 86
Pain 32 32
Reaction 31 31
Foreign Body In Patient 28 28
Bone Fracture(s) 21 21
Unspecified Infection 19 19
Device Embedded In Tissue or Plaque 10 10
Injury 9 9
Joint Dislocation 7 7
Limb Fracture 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Osteolysis 4 4
Joint Laxity 3 3
Metal Related Pathology 3 3
Loss of Range of Motion 3 3
Cyst(s) 3 3
Failure of Implant 2 2
Bruise/Contusion 2 2
Inflammation 2 2
Physical Asymmetry 2 2
Swelling/ Edema 1 1
Nerve Damage 1 1
Infiltration into Tissue 1 1
Synovitis 1 1
Tissue Damage 1 1
Paralysis 1 1
Adhesion(s) 1 1
Death 1 1
Fall 1 1
Foreign Body Reaction 1 1
Unspecified Musculoskeletal problem 1 1
Patient Problem/Medical Problem 1 1
Inadequate Osseointegration 1 1
Blood Loss 1 1
Joint Swelling 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Feb-12-2018
2 Biomet Microfixation, LLC II May-12-2017
3 DePuy Orthopaedics, Inc. II Jul-20-2022
4 Integra LifeSciences Corp. II Apr-20-2018
5 Materialise USA LLC II Aug-24-2022
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