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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device template
Regulation Description Template for clinical use.
Product CodeHWT
Regulation Number 888.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 938 938
2021 2177 2177
2022 2096 2096
2023 2601 2601
2024 2419 2419
2025 177 177

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4924 4924
Naturally Worn 1638 1638
Device-Device Incompatibility 1335 1335
Scratched Material 1116 1116
Crack 781 781
Detachment of Device or Device Component 718 718
Material Deformation 525 525
Illegible Information 388 388
Material Twisted/Bent 337 337
Contamination /Decontamination Problem 323 323
Fracture 265 265
Material Integrity Problem 207 207
No Apparent Adverse Event 176 176
Mechanical Jam 145 145
Material Discolored 144 144
Peeled/Delaminated 135 135
Adverse Event Without Identified Device or Use Problem 88 88
Entrapment of Device 72 72
Unintended Movement 70 70
Corroded 61 61
Use of Device Problem 52 52
Component Missing 45 45
Incorrect Measurement 44 44
Failure to Cut 43 43
Structural Problem 22 22
Physical Resistance/Sticking 16 16
Improper or Incorrect Procedure or Method 15 15
Mechanical Problem 14 14
Device Dislodged or Dislocated 14 14
Material Fragmentation 12 12
Insufficient Information 12 12
Compatibility Problem 11 11
Appropriate Term/Code Not Available 11 11
Off-Label Use 11 11
Dull, Blunt 9 9
Loss of Osseointegration 8 8
Difficult to Open or Close 8 8
Loose or Intermittent Connection 7 7
Loss of or Failure to Bond 7 7
Difficult or Delayed Separation 5 5
Migration 4 4
Residue After Decontamination 4 4
Device Slipped 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Remove 3 3
Material Split, Cut or Torn 3 3
Device Damaged Prior to Use 3 3
Inadequacy of Device Shape and/or Size 2 2
Activation, Positioning or Separation Problem 2 2
Patient-Device Incompatibility 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8602 8602
Insufficient Information 986 986
No Consequences Or Impact To Patient 660 660
No Code Available 121 121
No Patient Involvement 66 66
No Known Impact Or Consequence To Patient 42 42
Foreign Body In Patient 35 35
Pain 21 21
Bone Fracture(s) 17 17
Not Applicable 16 16
Unspecified Infection 13 13
No Information 11 11
Limb Fracture 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Physical Asymmetry 6 6
Joint Dislocation 5 5
Injury 4 4
Loss of Range of Motion 4 4
Joint Laxity 4 4
Cyst(s) 3 3
Metal Related Pathology 3 3
Unspecified Tissue Injury 3 3
Laceration(s) 2 2
Swelling/ Edema 2 2
Failure of Implant 2 2
Bruise/Contusion 2 2
Osteolysis 2 2
Unspecified Musculoskeletal problem 1 1
Inflammation 1 1
Foreign Body Reaction 1 1
Adhesion(s) 1 1
Device Embedded In Tissue or Plaque 1 1
Pulmonary Embolism 1 1
Ambulation Difficulties 1 1
Spinal Cord Injury 1 1
Unspecified Nervous System Problem 1 1
Nerve Damage 1 1
Non-union Bone Fracture 1 1
Depression 1 1
Synovitis 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jul-20-2022
2 LINK BIO CORP II Jul-25-2024
3 Materialise USA LLC II Aug-24-2022
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