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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, nonabsorbable, synthetic, polyethylene
Product CodeGAT
Regulation Number 878.5000
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLOSOURCE
  SUBSTANTIALLY EQUIVALENT 1
ARCURO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
S.B.M. SAS (SCIENCE & BIO MATERIALS)
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
THREADSTONE L.L.C.
  SUBSTANTIALLY EQUIVALENT 3
WINTER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1251 1251
2020 1225 1225
2021 1643 1765
2022 1419 1419
2023 2039 2039
2024 1727 1727

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 1791 1791
Break 1420 1420
Firing Problem 1401 1401
Adverse Event Without Identified Device or Use Problem 1036 1036
Material Separation 748 748
Device Dislodged or Dislocated 685 685
Premature Activation 602 602
Detachment of Device or Device Component 302 302
Activation, Positioning or Separation Problem 129 129
Failure to Advance 127 127
Unintended Ejection 113 113
Physical Resistance/Sticking 109 109
Material Split, Cut or Torn 108 108
Insufficient Information 106 106
Component Missing 66 66
Material Twisted/Bent 61 61
Failure to Cycle 51 51
Material Frayed 50 50
Misfire 41 41
Material Deformation 40 40
Activation Problem 37 37
Unraveled Material 37 37
Unstable 36 36
Product Quality Problem 36 36
Migration 35 35
Mechanical Problem 34 34
Patient Device Interaction Problem 34 34
Device Slipped 29 29
Mechanical Jam 29 29
Use of Device Problem 28 28
Defective Device 28 28
Positioning Failure 27 27
Device Fell 26 26
Component Misassembled 25 25
Crack 24 24
Material Integrity Problem 23 23
Nonstandard Device 23 23
Manufacturing, Packaging or Shipping Problem 23 23
Loose or Intermittent Connection 22 22
Device Markings/Labelling Problem 21 21
Delivered as Unsterile Product 21 21
Biocompatibility 19 19
Therapeutic or Diagnostic Output Failure 16 16
Patient-Device Incompatibility 16 16
Output Problem 15 15
Ejection Problem 15 15
Activation Failure 15 15
Packaging Problem 15 15
Dull, Blunt 14 14
Fracture 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5545 5545
No Known Impact Or Consequence To Patient 1181 1181
Insufficient Information 454 454
No Consequences Or Impact To Patient 406 406
Device Embedded In Tissue or Plaque 318 318
No Information 274 274
Foreign Body In Patient 230 230
Unspecified Infection 216 216
Pain 188 188
Not Applicable 136 136
Injury 101 101
Hemorrhage/Bleeding 87 87
No Code Available 81 81
Unspecified Tissue Injury 78 200
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 75
Wound Dehiscence 66 66
Inflammation 62 62
Hernia 53 53
Failure of Implant 49 49
Post Operative Wound Infection 48 48
Granuloma 46 46
Hematoma 40 40
Swelling/ Edema 31 31
Abscess 30 30
Obstruction/Occlusion 27 27
Impaired Healing 26 26
Erosion 26 26
Incontinence 25 25
Fever 24 24
Loss of Range of Motion 24 24
Adhesion(s) 24 24
Discomfort 22 22
Eye Injury 22 22
Fluid Discharge 22 22
Fibrosis 21 21
Sepsis 21 21
Foreign Body Reaction 20 20
Blood Loss 20 20
Fistula 20 20
Scar Tissue 19 19
No Patient Involvement 18 18
Seroma 17 17
Pocket Erosion 17 17
Damage to Ligament(s) 17 17
Nerve Damage 17 17
Urinary Tract Infection 16 16
Muscular Rigidity 16 16
Joint Dislocation 16 16
Failure to Anastomose 15 15
Perforation 15 15

Recalls
Manufacturer Recall Class Date Posted
1 ArthroCare Corporation II Sep-22-2020
2 Covidien, LP II Feb-25-2023
3 Musculoskeletal Transplant Foundation, Inc. II Sep-20-2019
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