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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
CONVENTUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NARANG MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 389 389
2015 316 316
2016 506 506
2017 287 287
2018 320 320
2019 490 490
2020 643 643
2021 630 630
2022 598 598
2023 357 357
2024 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1884 1884
Break 784 784
Device-Device Incompatibility 442 442
Insufficient Information 253 253
Fracture 229 229
Migration or Expulsion of Device 126 126
Migration 113 113
Device Operates Differently Than Expected 95 95
Material Deformation 68 68
Manufacturing, Packaging or Shipping Problem 65 65
Appropriate Term/Code Not Available 58 58
Failure to Align 57 57
Material Twisted/Bent 47 47
Fitting Problem 41 41
Unintended Movement 40 40
Mechanical Jam 38 38
Device Dislodged or Dislocated 33 33
Detachment of Device or Device Component 33 33
Loose or Intermittent Connection 30 30
No Apparent Adverse Event 29 29
Device Slipped 27 27
Difficult to Remove 24 24
Entrapment of Device 21 21
Loosening of Implant Not Related to Bone-Ingrowth 21 21
Bent 20 20
Connection Problem 20 20
Use of Device Problem 18 18
Sticking 17 17
Improper or Incorrect Procedure or Method 17 17
Crack 17 17
Difficult to Insert 16 16
Failure to Osseointegrate 16 16
Difficult to Advance 15 15
Material Fragmentation 14 14
Failure To Adhere Or Bond 13 13
Malposition of Device 12 12
Device Markings/Labelling Problem 11 11
Material Integrity Problem 11 11
Patient-Device Incompatibility 9 9
Defective Device 9 9
Material Protrusion/Extrusion 8 8
Device Difficult to Maintain 8 8
Compatibility Problem 7 7
Positioning Problem 7 7
Inadequacy of Device Shape and/or Size 7 7
Separation Failure 7 7
Component Missing 7 7
Mechanical Problem 7 7
Difficult To Position 7 7
Naturally Worn 6 6
Patient Device Interaction Problem 6 6
Packaging Problem 5 5
Delivered as Unsterile Product 5 5
Unstable 5 5
Contamination /Decontamination Problem 4 4
Nonstandard Device 4 4
Collapse 4 4
Device Damaged by Another Device 4 4
Scratched Material 3 3
Device Handling Problem 3 3
Incomplete or Inadequate Connection 3 3
Degraded 3 3
Material Separation 3 3
Loss of Osseointegration 3 3
Incomplete or Missing Packaging 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Advance 2 2
Component or Accessory Incompatibility 2 2
Activation, Positioning or Separation Problem 2 2
Device Operational Issue 2 2
Product Quality Problem 2 2
Positioning Failure 2 2
Detachment Of Device Component 2 2
Partial Blockage 2 2
Loss of or Failure to Bond 2 2
Material Discolored 2 2
Separation Problem 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 2 2
Mechanics Altered 2 2
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Material Distortion 1 1
Material Split, Cut or Torn 1 1
Noise, Audible 1 1
Misassembly by Users 1 1
Osseointegration Problem 1 1
Difficult or Delayed Separation 1 1
Premature Separation 1 1
Thickening of Material 1 1
Material Disintegration 1 1
Hole In Material 1 1
Device Expiration Issue 1 1
Component Incompatible 1 1
Disassembly 1 1
Off-Label Use 1 1
Material Puncture/Hole 1 1
Shelf Life Exceeded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 919 919
No Clinical Signs, Symptoms or Conditions 686 686
Non-union Bone Fracture 649 649
Failure of Implant 468 468
Pain 438 438
Unspecified Infection 425 425
Injury 400 400
No Known Impact Or Consequence To Patient 279 279
No Consequences Or Impact To Patient 223 223
Bone Fracture(s) 222 222
Impaired Healing 212 212
Insufficient Information 106 106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 85 85
Discomfort 84 84
No Information 72 72
Necrosis 65 65
Post Operative Wound Infection 57 57
Physical Asymmetry 55 55
Loss of Range of Motion 55 55
Foreign Body In Patient 48 48
Deformity/ Disfigurement 46 46
Sedation 42 42
Malunion of Bone 38 38
No Patient Involvement 35 35
Fall 31 31
Device Embedded In Tissue or Plaque 29 29
Skin Inflammation/ Irritation 27 27
Tissue Damage 27 27
Thrombosis/Thrombus 24 24
Irritation 23 23
Inflammation 22 22
Nerve Damage 22 22
Perforation 21 21
Hip Fracture 18 18
Ambulation Difficulties 18 18
Hematoma 16 16
Reaction 15 15
Not Applicable 14 14
Hypersensitivity/Allergic reaction 14 14
Patient Problem/Medical Problem 13 13
Unspecified Tissue Injury 13 13
Ossification 12 12
Skin Irritation 11 11
Joint Dislocation 11 11
Bacterial Infection 10 10
Cellulitis 9 9
Implant Pain 8 8
Limb Fracture 7 7
Swelling/ Edema 7 7
Death 7 7
Swelling 7 7
Muscular Rigidity 7 7
Fracture, Arm 6 6
Paralysis 6 6
Inadequate Osseointegration 6 6
Skin Infection 5 5
Rash 5 5
Sepsis 5 5
Pulmonary Embolism 5 5
Abscess 4 4
Wound Dehiscence 4 4
Arthritis 4 4
Muscle Weakness 4 4
Thrombosis 4 4
Unequal Limb Length 4 4
Joint Laxity 4 4
Fluid Discharge 4 4
Blood Loss 3 3
Numbness 3 3
Hypoesthesia 3 3
Infiltration into Tissue 3 3
Fever 3 3
Calcium Deposits/Calcification 3 3
Anemia 2 2
Hemorrhage/Bleeding 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Arthralgia 2 2
Weakness 2 2
Therapeutic Response, Decreased 2 2
Ulcer 2 2
Skin Erosion 2 2
Scar Tissue 2 2
Pocket Erosion 2 2
Neuropathy 2 2
Confusion/ Disorientation 2 2
Limited Mobility Of The Implanted Joint 2 2
Muscle/Tendon Damage 2 2
Osteomyelitis 2 2
Vertebral Fracture 2 2
Embolism/Embolus 2 2
Movement Disorder 1 1
Hyperextension 1 1
Joint Contracture 1 1
Skin Disorders 1 1
Fibrosis 1 1
Pseudoaneurysm 1 1
Low Oxygen Saturation 1 1
Osteopenia/ Osteoporosis 1 1
Intraoperative Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew Inc II May-20-2014
2 Smith & Nephew Inc II Mar-13-2013
3 Smith & Nephew Orthopaedics GmbH II May-25-2022
4 Smith & Nephew, Inc. II Jan-06-2021
5 Smith & Nephew, Inc. II Jul-22-2020
6 Smith & Nephew, Inc. II Nov-16-2017
7 Smith & Nephew, Inc. II Aug-17-2014
8 Stryker Howmedica Osteonics Corp. II Jun-01-2009
9 Synthes (USA) Products LLC II Nov-26-2013
10 Synthes USA (HQ), Inc. II May-07-2010
11 Synthes USA HQ, Inc. II Nov-27-2013
12 Synthes, Inc. II Jul-08-2015
13 Zimmer Biomet, Inc. II Mar-27-2017
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