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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nail, fixation, bone
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
NARANG MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 643 643
2021 630 630
2022 589 589
2023 357 357
2024 467 467
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1110 1110
Device-Device Incompatibility 522 522
Break 454 454
Fracture 113 113
Migration 113 113
Insufficient Information 81 81
Material Deformation 73 73
Manufacturing, Packaging or Shipping Problem 65 65
Material Twisted/Bent 46 46
Detachment of Device or Device Component 42 42
Migration or Expulsion of Device 33 33
Use of Device Problem 19 19
Entrapment of Device 18 18
Loose or Intermittent Connection 18 18
No Apparent Adverse Event 17 17
Crack 16 16
Improper or Incorrect Procedure or Method 14 14
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Device Slipped 13 13
Material Integrity Problem 13 13
Difficult to Advance 12 12
Appropriate Term/Code Not Available 12 12
Failure to Align 11 11
Connection Problem 10 10
Defective Device 9 9
Delivered as Unsterile Product 8 8
Device Dislodged or Dislocated 8 8
Illegible Information 6 6
Device Markings/Labelling Problem 6 6
Naturally Worn 6 6
Malposition of Device 5 5
Component Missing 5 5
Mechanical Jam 4 4
Difficult to Insert 4 4
Nonstandard Device 4 4
Tear, Rip or Hole in Device Packaging 3 3
Scratched Material 3 3
Material Separation 3 3
Packaging Problem 3 3
Unintended Movement 3 3
Positioning Failure 3 3
Contamination /Decontamination Problem 2 2
Product Quality Problem 2 2
Activation, Positioning or Separation Problem 2 2
Patient Device Interaction Problem 2 2
Separation Problem 2 2
Loss of Osseointegration 2 2
Deformation Due to Compressive Stress 2 2
Unsealed Device Packaging 2 2
Mechanical Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 859 859
Non-union Bone Fracture 366 366
Failure of Implant 245 245
Injury 215 215
No Code Available 203 203
Unspecified Infection 198 198
Insufficient Information 197 197
Pain 156 156
Bone Fracture(s) 117 117
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 85 85
Physical Asymmetry 67 67
No Consequences Or Impact To Patient 64 64
Post Operative Wound Infection 50 50
Deformity/ Disfigurement 49 49
Malunion of Bone 48 48
Necrosis 38 38
Discomfort 38 38
No Known Impact Or Consequence To Patient 35 35
Impaired Healing 31 31
Skin Inflammation/ Irritation 29 29
Loss of Range of Motion 29 29
Thrombosis/Thrombus 25 25
Foreign Body In Patient 24 24
Inflammation 20 20
Implant Pain 19 19
Perforation 19 19
Ambulation Difficulties 15 15
Unspecified Tissue Injury 15 15
Nerve Damage 14 14
Fall 13 13
No Patient Involvement 13 13
Hip Fracture 12 12
Tissue Damage 11 11
Hematoma 11 11
No Information 10 10
Muscular Rigidity 9 9
Swelling/ Edema 9 9
Bacterial Infection 9 9
Ossification 8 8
Joint Dislocation 8 8
Device Embedded In Tissue or Plaque 8 8
Limb Fracture 7 7
Fluid Discharge 7 7
Muscle Weakness 6 6
Reaction 6 6
Cellulitis 6 6
Skin Irritation 5 5
Skin Infection 5 5
Osteomyelitis 5 5
Hypersensitivity/Allergic reaction 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew Orthopaedics GmbH II May-25-2022
2 Smith & Nephew, Inc. II Jan-06-2021
3 Smith & Nephew, Inc. II Jul-22-2020
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