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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
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 638 638
2022 464 464

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1226 1226
Break 456 456
Device-Device Incompatibility 270 270
Insufficient Information 199 199
Fracture 153 153
Migration 82 82
Manufacturing, Packaging or Shipping Problem 63 63
Migration or Expulsion of Device 62 62
Material Deformation 44 44
Material Twisted/Bent 35 35
Loose or Intermittent Connection 27 27
No Apparent Adverse Event 26 26
Failure to Align 24 24
Appropriate Term/Code Not Available 23 23
Unintended Movement 22 22
Connection Problem 19 19
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Device Operates Differently Than Expected 18 18
Entrapment of Device 16 16
Device Slipped 15 15
Detachment of Device or Device Component 14 14
Improper or Incorrect Procedure or Method 13 13
Device Dislodged or Dislocated 12 12
Mechanical Jam 11 11
Use of Device Problem 11 11
Patient-Device Incompatibility 9 9
Device Difficult to Maintain 8 8
Malposition of Device 7 7
Material Fragmentation 7 7
Crack 6 6
Component Missing 6 6
Naturally Worn 6 6
Difficult to Advance 6 6
Device Markings/Labelling Problem 5 5
Fitting Problem 5 5
Patient Device Interaction Problem 5 5
Defective Device 4 4
Nonstandard Device 4 4
Difficult to Remove 4 4
Mechanical Problem 4 4
Difficult to Insert 3 3
Bent 3 3
Material Separation 3 3
Inadequacy of Device Shape and/or Size 3 3
Packaging Problem 3 3
Positioning Problem 3 3
Scratched Material 3 3
Incomplete or Inadequate Connection 3 3
Physical Resistance/Sticking 2 2
Device Handling Problem 2 2
Separation Failure 2 2
Device Operational Issue 2 2
Device Damaged by Another Device 2 2
Activation, Positioning or SeparationProblem 2 2
Product Quality 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 Osseointegration 2 2
Loss of or Failure to Bond 2 2
Failure To Adhere Or Bond 2 2
Misassembled 1 1
Misconnection 1 1
Detachment Of Device Component 1 1
Component Incompatible 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
Off-Label Use 1 1
Material Puncture/Hole 1 1
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult or Delayed Activation 1 1
Failure to Advance 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
Noise, Audible 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Separation Problem 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 Code Available 534 534
Injury 395 395
No Clinical Signs, Symptoms or Conditions 390 390
Non-union Bone Fracture 382 382
Failure of Implant 265 265
Unspecified Infection 240 240
No Consequences Or Impact To Patient 208 208
Pain 201 201
Bone Fracture(s) 146 146
No Known Impact Or Consequence To Patient 105 105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 85 85
Impaired Healing 70 70
Discomfort 54 54
Necrosis 53 53
No Information 46 46
Physical Asymmetry 44 44
Post Operative Wound Infection 43 43
Deformity/ Disfigurement 38 38
Loss of Range of Motion 37 37
Foreign Body In Patient 37 37
Malunion of Bone 35 35
No Patient Involvement 29 29
Insufficient Information 27 27
Thrombosis/Thrombus 23 23
Skin Inflammation/ Irritation 21 21
Tissue Damage 19 19
Perforation 16 16
Nerve Damage 15 15
Hypersensitivity/Allergic reaction 14 14
Not Applicable 14 14
Ambulation Difficulties 13 13
Hip Fracture 13 13
Device Embedded In Tissue or Plaque 11 11
Fall 10 10
Hematoma 9 9
Bacterial Infection 9 9
Joint Dislocation 9 9
Inflammation 8 8
Unspecified Tissue Injury 8 8
Muscular Rigidity 7 7
Death 7 7
Reaction 7 7
Skin Irritation 7 7
Ossification 5 5
Paralysis 5 5
Limb Fracture 5 5
Joint Laxity 4 4
Implant Pain 4 4
Skin Infection 4 4
Inadequate Osseointegration 4 4
Pulmonary Embolism 4 4
Abscess 3 3
Arthritis 3 3
Cellulitis 3 3
Fever 3 3
Irritation 3 3
Swelling 3 3
Rash 3 3
Thrombosis 3 3
Hypoesthesia 3 3
Swelling/ Edema 3 3
Embolism/Embolus 2 2
Vertebral Fracture 2 2
Muscle/Tendon Damage 2 2
Unequal Limb Length 2 2
Confusion/ Disorientation 2 2
Patient Problem/Medical Problem 2 2
Arthralgia 2 2
Sedation 2 2
Numbness 2 2
Weakness 2 2
Muscle Weakness 2 2
Pocket Erosion 2 2
Neuropathy 2 2
Wound Dehiscence 2 2
Calcium Deposits/Calcification 1 1
Adhesion(s) 1 1
Abrasion 1 1
Hemorrhage/Bleeding 1 1
Cyst(s) 1 1
Edema 1 1
Extravasation 1 1
Internal Organ Perforation 1 1
Neovascularization 1 1
Hypoxia 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Tingling 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Urticaria 1 1
Scar Tissue 1 1
Skin Erosion 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Bronchopneumonia 1 1
Low Oxygen Saturation 1 1
Osteolysis 1 1
Ventilator Dependent 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
4 Smith & Nephew, Inc. II Nov-16-2017
5 Zimmer Biomet, Inc. II Mar-27-2017
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