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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
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 287 287
2018 320 320
2019 490 490
2020 644 644
2021 637 637

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 979 979
Break 398 398
Device-Device Incompatibility 223 223
Insufficient Information 199 199
Fracture 126 126
Manufacturing, Packaging or Shipping Problem 63 63
Migration or Expulsion of Device 54 54
Migration 53 53
Material Deformation 30 30
Loose or Intermittent Connection 27 27
No Apparent Adverse Event 26 26
Material Twisted/Bent 23 23
Failure to Align 23 23
Unintended Movement 22 22
Appropriate Term/Code Not Available 21 21
Connection Problem 19 19
Device Operates Differently Than Expected 18 18
Entrapment of Device 16 16
Device Slipped 14 14
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Detachment of Device or Device Component 13 13
Device Dislodged or Dislocated 12 12
Improper or Incorrect Procedure or Method 12 12
Use of Device Problem 10 10
Mechanical Jam 9 9
Patient-Device Incompatibility 9 9
Device Difficult to Maintain 8 8
Naturally Worn 6 6
Material Fragmentation 6 6
Crack 5 5
Fitting Problem 5 5
Patient Device Interaction Problem 5 5
Component Missing 4 4
Mechanical Problem 4 4
Defective Device 4 4
Device Markings/Labelling Problem 4 4
Difficult to Advance 3 3
Difficult to Insert 3 3
Bent 3 3
Inadequacy of Device Shape and/or Size 3 3
Nonstandard Device 3 3
Difficult to Remove 3 3
Material Separation 3 3
Incomplete or Inadequate Connection 3 3
Physical Resistance/Sticking 2 2
Device Handling Problem 2 2
Sticking 2 2
Unstable 2 2
Incomplete or Missing Packaging 2 2
Tear, Rip or Hole in Device Packaging 2 2
Loss of or Failure to Bond 2 2
Failure To Adhere Or Bond 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Malposition of Device 2 2
Separation Failure 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Scratched Material 1 1
Torn Material 1 1
Misassembly by Users 1 1
Osseointegration Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Difficult or Delayed Activation 1 1
Failure to Advance 1 1
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Activation, Positioning or SeparationProblem 1 1
Misassembled 1 1
Misconnection 1 1
Detachment Of Device Component 1 1
Degraded 1 1
Disassembly 1 1
Material Discolored 1 1
Material Disintegration 1 1
Shipping Damage or Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Delivered as Unsterile Product 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Noise, Audible 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Thickening of Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 534 534
Injury 395 395
Non-union Bone Fracture 320 320
No Clinical Signs, Symptoms or Conditions 263 263
Failure of Implant 211 211
Unspecified Infection 211 211
No Consequences Or Impact To Patient 208 208
Pain 178 178
No Known Impact Or Consequence To Patient 105 105
Bone Fracture(s) 104 104
Impaired Healing 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
No Information 46 46
Necrosis 42 42
Discomfort 41 41
Physical Asymmetry 40 40
Foreign Body In Patient 33 33
No Patient Involvement 29 29
Post Operative Wound Infection 29 29
Loss of Range of Motion 27 27
Skin Inflammation/ Irritation 20 20
Tissue Damage 19 19
Malunion of Bone 16 16
Not Applicable 14 14
Insufficient Information 12 12
Device Embedded In Tissue or Plaque 11 11
Nerve Damage 11 11
Hypersensitivity/Allergic reaction 10 10
Hip Fracture 9 9
Ambulation Difficulties 9 9
Joint Dislocation 9 9
Deformity/ Disfigurement 8 8
Bacterial Infection 8 8
Hematoma 7 7
Fall 7 7
Death 7 7
Inflammation 7 7
Reaction 7 7
Muscular Rigidity 7 7
Skin Irritation 7 7
Unspecified Tissue Injury 7 7
Paralysis 5 5
Implant Pain 4 4
Joint Laxity 4 4
Rash 3 3
Irritation 3 3
Cellulitis 3 3
Fever 3 3
Arthritis 3 3
Ossification 3 3
Pulmonary Embolism 3 3
Abscess 3 3
Swelling 3 3
Hypoesthesia 3 3
Thrombosis 3 3
Sedation 2 2
Numbness 2 2
Pocket Erosion 2 2
Weakness 2 2
Wound Dehiscence 2 2
Swelling/ Edema 2 2
Patient Problem/Medical Problem 2 2
Thrombosis/Thrombus 2 2
Vertebral Fracture 1 1
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Unequal Limb Length 1 1
Skin Infection 1 1
Osteopenia/ Osteoporosis 1 1
Intraoperative Pain 1 1
Fluid Discharge 1 1
Calcium Deposits/Calcification 1 1
Adhesion(s) 1 1
Abrasion 1 1
Hemorrhage/Bleeding 1 1
Cyst(s) 1 1
Edema 1 1
Itching Sensation 1 1
Damage to Ligament(s) 1 1
Hypoxia 1 1
Neovascularization 1 1
Scar Tissue 1 1
Skin Erosion 1 1
Perforation 1 1
Neuropathy 1 1
Tingling 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Arthralgia 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Urticaria 1 1
Bronchopneumonia 1 1
Ventilator Dependent 1 1
Pseudoaneurysm 1 1
Low Oxygen Saturation 1 1
Osteolysis 1 1
Disability 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Jan-06-2021
2 Smith & Nephew, Inc. II Jul-22-2020
3 Smith & Nephew, Inc. II Nov-16-2017
4 Zimmer Biomet, Inc. II Mar-27-2017
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