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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
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 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 490 490
2020 643 643
2021 630 630
2022 598 598
2023 357 357
2024 120 120

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1114 1114
Break 482 482
Device-Device Incompatibility 419 419
Insufficient Information 160 160
Fracture 147 147
Migration 111 111
Manufacturing, Packaging or Shipping Problem 65 65
Material Deformation 65 65
Material Twisted/Bent 43 43
Migration or Expulsion of Device 41 41
Detachment of Device or Device Component 27 27
No Apparent Adverse Event 27 27
Loose or Intermittent Connection 26 26
Entrapment of Device 21 21
Loosening of Implant Not Related to Bone-Ingrowth 21 21
Device Slipped 18 18
Use of Device Problem 17 17
Improper or Incorrect Procedure or Method 16 16
Failure to Align 16 16
Appropriate Term/Code Not Available 16 16
Connection Problem 14 14
Difficult to Advance 13 13
Crack 13 13
Material Integrity Problem 10 10
Device Dislodged or Dislocated 9 9
Defective Device 9 9
Device Markings/Labelling Problem 7 7
Device Difficult to Maintain 6 6
Patient Device Interaction Problem 6 6
Naturally Worn 5 5
Malposition of Device 5 5
Difficult to Insert 5 5
Component Missing 5 5
Nonstandard Device 4 4
Unintended Movement 4 4
Scratched Material 3 3
Packaging Problem 3 3
Mechanical Jam 3 3
Inadequacy of Device Shape and/or Size 3 3
Delivered as Unsterile Product 3 3
Fitting Problem 3 3
Material Separation 3 3
Device Handling Problem 3 3
Incomplete or Inadequate Connection 3 3
Separation Problem 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 2 2
Unstable 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Incomplete or Missing Packaging 2 2
Tear, Rip or Hole in Device Packaging 2 2
Loss of Osseointegration 2 2
Mechanical Problem 2 2
Material Fragmentation 2 2
Positioning Failure 2 2
Contamination /Decontamination Problem 2 2
Activation, Positioning or Separation Problem 2 2
Device Damaged by Another Device 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Positioning Problem 1 1
Osseointegration Problem 1 1
Misassembly by Users 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Biocompatibility 1 1
Deformation Due to Compressive Stress 1 1
Failure to Advance 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Material Discolored 1 1
Material Disintegration 1 1
Degraded 1 1
Component Incompatible 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Device Damaged Prior to Use 1 1
Misassembled 1 1
Shipping Damage or Problem 1 1
Material Split, Cut or Torn 1 1
Difficult or Delayed Separation 1 1
Premature Separation 1 1
Thickening of Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 696 696
Injury 350 350
No Code Available 340 340
Non-union Bone Fracture 326 326
Failure of Implant 244 244
Unspecified Infection 229 229
Pain 168 168
No Consequences Or Impact To Patient 168 168
Bone Fracture(s) 128 128
Insufficient Information 111 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 85 85
Physical Asymmetry 56 56
Post Operative Wound Infection 48 48
No Known Impact Or Consequence To Patient 46 46
Deformity/ Disfigurement 46 46
Necrosis 41 41
Discomfort 39 39
Impaired Healing 39 39
Malunion of Bone 38 38
Foreign Body In Patient 35 35
Loss of Range of Motion 28 28
Skin Inflammation/ Irritation 27 27
No Patient Involvement 26 26
Thrombosis/Thrombus 24 24
No Information 23 23
Inflammation 19 19
Perforation 18 18
Nerve Damage 14 14
Hypersensitivity/Allergic reaction 13 13
Ambulation Difficulties 13 13
Unspecified Tissue Injury 13 13
Tissue Damage 12 12
Hip Fracture 12 12
Fall 11 11
Hematoma 9 9
Bacterial Infection 9 9
Joint Dislocation 8 8
Implant Pain 8 8
Swelling/ Edema 7 7
Limb Fracture 7 7
Not Applicable 7 7
Device Embedded In Tissue or Plaque 7 7
Ossification 7 7
Muscular Rigidity 7 7
Cellulitis 6 6
Reaction 6 6
Skin Irritation 6 6
Inadequate Osseointegration 5 5
Skin Infection 5 5
Joint Laxity 4 4
Unequal Limb Length 4 4
Muscle Weakness 4 4
Paralysis 4 4
Hypoesthesia 3 3
Arthralgia 3 3
Thrombosis 3 3
Fluid Discharge 3 3
Vertebral Fracture 2 2
Muscle/Tendon Damage 2 2
Osteomyelitis 2 2
Embolism/Embolus 2 2
Pocket Erosion 2 2
Numbness 2 2
Confusion/ Disorientation 2 2
Neuropathy 2 2
Rash 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Wound Dehiscence 2 2
Pulmonary Embolism 2 2
Abscess 2 2
Calcium Deposits/Calcification 2 2
Anemia 2 2
Arthritis 2 2
Adhesion(s) 1 1
Abrasion 1 1
Fistula 1 1
Death 1 1
Extravasation 1 1
Scar Tissue 1 1
Sepsis 1 1
Internal Organ Perforation 1 1
Neovascularization 1 1
Irritation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Electric Shock 1 1
Bronchopneumonia 1 1
Osteopenia/ Osteoporosis 1 1
Osteolysis 1 1
Fibrosis 1 1
Patient Problem/Medical Problem 1 1
Swelling 1 1
Synovitis 1 1
Weakness 1 1
Ulcer 1 1
Urticaria 1 1
Depression 1 1
Joint Contracture 1 1

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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