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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
2018 713 713
2019 741 741
2020 938 938
2021 2183 2183
2022 2115 2115
2023 1030 1030

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3530 3530
Naturally Worn 1021 1021
Device-Device Incompatibility 1005 1005
Crack 620 620
Scratched Material 555 555
Material Twisted/Bent 406 406
Detachment of Device or Device Component 400 400
Material Deformation 319 319
Fracture 314 314
Contamination /Decontamination Problem 227 227
Illegible Information 189 189
Material Integrity Problem 169 169
Material Discolored 126 126
Mechanical Jam 114 114
Component Missing 100 100
Adverse Event Without Identified Device or Use Problem 84 84
Peeled/Delaminated 67 67
Appropriate Term/Code Not Available 65 65
Entrapment of Device 56 56
Use of Device Problem 54 54
Unintended Movement 50 50
Failure to Cut 45 45
Insufficient Information 41 41
Physical Resistance/Sticking 40 40
No Apparent Adverse Event 39 39
Corroded 35 35
Incorrect Measurement 33 33
Loose or Intermittent Connection 25 25
Dull, Blunt 20 20
Device Dislodged or Dislocated 19 19
Structural Problem 18 18
Mechanical Problem 17 17
Difficult to Remove 16 16
Connection Problem 16 16
Compatibility Problem 12 12
Difficult to Insert 8 8
Material Fragmentation 7 7
Improper or Incorrect Procedure or Method 7 7
Loss of Osseointegration 7 7
Difficult to Open or Close 6 6
Fitting Problem 6 6
Inadequacy of Device Shape and/or Size 6 6
Device Slipped 6 6
Disassembly 6 6
Separation Problem 6 6
Migration 5 5
Off-Label Use 5 5
Separation Failure 5 5
Defective Device 5 5
Device Issue 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Bent 4 4
Positioning Problem 4 4
Material Split, Cut or Torn 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Loss of or Failure to Bond 3 3
Degraded 3 3
Device Damaged Prior to Use 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Markings/Labelling Problem 3 3
Malposition of Device 3 3
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Tear, Rip or Hole in Device Packaging 2 2
Defective Component 2 2
Pitted 2 2
Material Disintegration 2 2
Device Handling Problem 2 2
Patient Device Interaction Problem 2 2
Incomplete or Inadequate Connection 2 2
Difficult or Delayed Separation 1 1
Inaccurate Information 1 1
Misassembly by Users 1 1
Device Difficult to Maintain 1 1
Packaging Problem 1 1
Mechanics Altered 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
Detachment Of Device Component 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Unstable 1 1
Material Separation 1 1
Metal Shedding Debris 1 1
Failure to Align 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Difficult to Advance 1 1
Lack of Maintenance Documentation or Guidelines 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5206 5206
No Consequences Or Impact To Patient 1771 1771
Insufficient Information 207 207
No Code Available 139 139
No Patient Involvement 115 115
No Known Impact Or Consequence To Patient 111 111
No Information 102 102
Not Applicable 86 86
Pain 34 34
Foreign Body In Patient 24 24
Bone Fracture(s) 21 21
Reaction 20 20
Unspecified Infection 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Joint Dislocation 7 7
Limb Fracture 7 7
Injury 6 6
Joint Laxity 5 5
Device Embedded In Tissue or Plaque 5 5
Loss of Range of Motion 4 4
Cyst(s) 3 3
Metal Related Pathology 3 3
Osteolysis 3 3
Unspecified Tissue Injury 3 3
Physical Asymmetry 2 2
Swelling/ Edema 2 2
Bruise/Contusion 2 2
Ambulation Difficulties 2 2
Failure of Implant 2 2
Laceration(s) 2 2
Nerve Damage 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Synovitis 1 1
Discomfort 1 1
Pulmonary Embolism 1 1
Adhesion(s) 1 1
Death 1 1
Fall 1 1
Foreign Body Reaction 1 1
Inadequate Osseointegration 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Unspecified Musculoskeletal problem 1 1
Patient Problem/Medical Problem 1 1

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