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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device fastener, fixation, biodegradable, soft tissue
Product CodeMAI
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUITIVE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ACUITIVE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 17
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO, CORP
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 7
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NANOVA BIOMATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARCUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
S.B.M SAS SCIENCE FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
S.B.M. SAS SCIENCES FOR BIO MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPORTWELDING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIPTEK, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 478 478
2018 1590 1590
2019 1247 1247
2020 957 957
2021 1267 1267
2022 1189 1189

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3518 3518
Adverse Event Without Identified Device or Use Problem 774 774
Device-Device Incompatibility 268 268
Crack 198 198
Migration or Expulsion of Device 176 176
Fracture 170 170
Migration 162 162
Detachment of Device or Device Component 145 145
Material Deformation 136 136
Positioning Failure 124 124
Material Separation 120 120
Material Twisted/Bent 115 115
Insufficient Information 87 87
Material Split, Cut or Torn 83 83
Activation, Positioning or Separation Problem 79 79
Material Frayed 75 75
Device Dislodged or Dislocated 69 69
Loose or Intermittent Connection 61 61
Mechanical Jam 56 56
Difficult to Advance 55 55
Entrapment of Device 55 55
Premature Activation 51 51
Material Fragmentation 48 48
Failure to Advance 47 47
Patient-Device Incompatibility 45 45
Deformation Due to Compressive Stress 39 39
Device Damaged Prior to Use 36 36
Appropriate Term/Code Not Available 34 34
Detachment Of Device Component 29 29
Difficult to Insert 27 27
Difficult to Remove 27 27
Mechanical Problem 23 23
Unintended Movement 23 23
Activation Problem 22 22
Patient Device Interaction Problem 21 21
Bent 21 21
Positioning Problem 20 20
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Separation Failure 18 18
Firing Problem 17 17
Device Slipped 14 14
Use of Device Problem 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Device Operates Differently Than Expected 11 11
Physical Resistance/Sticking 11 11
Component Missing 11 11
Loss of or Failure to Bond 10 10
Failure to Fire 10 10
Expulsion 9 9
Output Problem 9 9
Delivered as Unsterile Product 9 9
Material Rupture 8 8
Packaging Problem 8 8
Material Integrity Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Unstable 6 6
Unsealed Device Packaging 6 6
Difficult or Delayed Positioning 6 6
Disconnection 6 6
Misfire 6 6
Device Damaged by Another Device 5 5
Device Fell 5 5
Flaked 5 5
Fitting Problem 5 5
Nonstandard Device 5 5
Product Quality Problem 5 5
Unraveled Material 4 4
Device Contamination with Chemical or Other Material 4 4
Material Protrusion/Extrusion 3 3
Defective Device 3 3
Split 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
No Apparent Adverse Event 3 3
Peeled/Delaminated 3 3
Material Disintegration 3 3
Component Falling 3 3
Failure To Adhere Or Bond 3 3
Component Incompatible 2 2
Material Invagination 2 2
Defective Component 2 2
Structural Problem 2 2
Device Appears to Trigger Rejection 2 2
Misassembled 2 2
Sticking 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Program or Algorithm Execution Problem 2 2
Noise, Audible 2 2
Suction Failure 2 2
Separation Problem 2 2
Failure to Disconnect 2 2
Malposition of Device 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Installation-Related Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Naturally Worn 1 1
Operating System Becomes Nonfunctional 1 1
Device Markings/Labelling Problem 1 1
Physical Resistance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2205 2205
No Clinical Signs, Symptoms or Conditions 1857 1857
No Known Impact Or Consequence To Patient 616 616
Not Applicable 369 369
Unspecified Tissue Injury 271 271
Foreign Body In Patient 250 250
Tissue Damage 243 243
No Code Available 218 218
Unspecified Infection 201 201
Injury 192 192
Pain 173 174
Insufficient Information 151 151
No Information 148 148
Device Embedded In Tissue or Plaque 114 114
Failure of Implant 64 64
Inflammation 47 47
Loss of Range of Motion 43 43
Swelling 35 35
Rupture 33 33
Hypersensitivity/Allergic reaction 31 31
Nerve Damage 29 29
Reaction 23 23
Foreign Body Reaction 22 22
No Patient Involvement 16 16
Joint Laxity 16 16
Cyst(s) 15 15
Rash 13 13
Impaired Healing 13 13
Adhesion(s) 12 12
Fever 12 12
Swelling/ Edema 11 11
Joint Dislocation 10 10
Erythema 10 10
Bacterial Infection 9 9
Hematoma 9 9
Hemorrhage/Bleeding 9 9
Scar Tissue 8 8
Post Operative Wound Infection 8 8
Fluid Discharge 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Osteolysis 7 7
Discomfort 7 7
Perforation 7 7
Abscess 7 7
Fatigue 6 6
Edema 6 6
Bone Fracture(s) 6 6
Local Reaction 6 6
Staphylococcus Aureus 5 5
Damage to Ligament(s) 5 5
Purulent Discharge 5 5
Numbness 5 5
Thrombosis/Thrombus 5 5
Muscle/Tendon Damage 4 4
Arthralgia 4 4
Wound Dehiscence 4 4
Nausea 4 4
Skin Discoloration 4 4
Dizziness 4 4
Weakness 4 4
Synovitis 3 3
Thrombus 3 3
Skin Irritation 3 3
Necrosis 3 3
Death 3 3
Autoimmune Disorder 3 3
Itching Sensation 3 3
Headache 3 3
Urticaria 3 3
Joint Disorder 3 3
Ulcer 2 2
Neck Stiffness 2 2
Anxiety 2 2
Malaise 2 2
Weight Changes 2 2
Limited Mobility Of The Implanted Joint 2 2
Tissue Breakdown 2 2
Alteration In Body Temperature 2 2
Patient Problem/Medical Problem 2 2
Osteomyelitis 2 2
Localized Skin Lesion 2 2
Reaction to Medicinal Component of Device 2 2
Laceration(s) 2 2
Muscle Spasm(s) 2 2
Cellulitis 2 2
Arthritis 2 2
Burning Sensation 2 2
Twitching 1 1
Cramp(s) 1 1
Tinnitus 1 1
Perforation of Vessels 1 1
Visual Impairment 1 1
Discharge 1 1
Therapeutic Response, Decreased 1 1
Paralysis 1 1
Scarring 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Embolism 1 1
Emotional Changes 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Jul-21-2021
2 Arthrex, Inc. II May-05-2017
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-10-2019
4 Smith & Nephew, Inc. II Apr-29-2021
5 Smith & Nephew, Inc. II Oct-21-2020
6 Smith & Nephew, Inc. II Apr-26-2018
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