• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
CETERIX ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 3
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
WINTER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1104 1104
2018 1452 1452
2019 1251 1251
2020 1226 1226
2021 1643 1765
2022 440 440

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1187 1187
Firing Problem 818 818
Failure to Fire 665 665
Adverse Event Without Identified Device or Use Problem 641 641
Activation, Positioning or SeparationProblem 571 571
Premature Activation 482 482
Material Separation 393 393
Positioning Failure 363 363
Detachment of Device or Device Component 220 220
Device Dislodged or Dislocated 216 216
Device Operates Differently Than Expected 168 168
Detachment Of Device Component 146 146
Unintended Ejection 113 113
Appropriate Term/Code Not Available 111 111
Insufficient Information 94 94
Misfire 69 69
Loose or Intermittent Connection 62 62
Material Split, Cut or Torn 61 61
Component Falling 56 56
Activation Problem 55 55
Device Fell 52 52
Material Twisted/Bent 46 46
Failure to Advance 44 44
Mechanical Problem 43 43
Material Frayed 41 41
Patient-Device Incompatibility 38 38
Component Missing 34 34
Physical Resistance/Sticking 32 32
Mechanical Jam 30 30
Migration or Expulsion of Device 29 29
Device Slipped 28 28
Use of Device Problem 25 25
Crack 25 25
Device Markings/Labelling Problem 24 24
Material Integrity Problem 23 23
Packaging Problem 21 21
Biocompatibility 19 19
Positioning Problem 18 18
Patient Device Interaction Problem 18 18
Manufacturing, Packaging or Shipping Problem 18 18
Unstable 18 18
Difficult to Remove 18 18
Migration 18 18
Retraction Problem 17 17
Unraveled Material 17 17
Tear, Rip or Hole in Device Packaging 17 17
Difficult to Insert 16 16
Material Deformation 15 15
Ejection Problem 15 15
Material Fragmentation 14 14
Sticking 14 14
Product Quality Problem 14 14
Unsealed Device Packaging 13 13
Entrapment of Device 13 13
Failure to Cycle 12 12
Therapeutic or Diagnostic Output Failure 12 12
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Nonstandard Device 11 11
Delivered as Unsterile Product 11 11
Device Inoperable 11 11
Defective Component 10 10
Malposition of Device 10 10
Component Misassembled 10 10
Contamination /Decontamination Problem 9 9
Dull, Blunt 9 9
Output Problem 9 9
Component Incompatible 9 9
Disconnection 8 8
No Apparent Adverse Event 8 8
Device Contamination with Chemical or Other Material 8 8
Expulsion 8 8
Material Protrusion/Extrusion 7 7
Expiration Date Error 7 7
Separation Failure 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Bent 7 7
Separation Problem 7 7
Contamination 6 6
Improper or Incorrect Procedure or Method 6 6
Peeled/Delaminated 6 6
Failure to Align 6 6
Activation Failure 6 6
Unintended Movement 5 5
Human-Device Interface Problem 5 5
Physical Resistance 5 5
Defective Device 5 5
Material Rupture 5 5
Material Erosion 5 5
Fracture 4 4
Partial Blockage 4 4
Device Damaged Prior to Use 4 4
Split 4 4
Difficult to Open or Close 4 4
Connection Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Noise, Audible 4 4
Mechanics Altered 3 3
Difficult To Position 3 3
Loss of or Failure to Bond 3 3
Difficult to Fold, Unfold or Collapse 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2819 2819
No Clinical Signs, Symptoms or Conditions 1823 1823
No Consequences Or Impact To Patient 855 855
No Information 344 344
Not Applicable 267 267
No Code Available 202 202
Unspecified Infection 166 166
Pain 142 142
Injury 115 115
Foreign Body In Patient 114 114
Insufficient Information 111 111
Inflammation 59 59
Hernia 56 56
Post Operative Wound Infection 53 53
Wound Dehiscence 48 48
Device Embedded In Tissue or Plaque 47 47
Blood Loss 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 44
Hemorrhage/Bleeding 42 42
Erosion 41 41
Hematoma 39 39
Granuloma 37 37
Abscess 36 36
Seroma 33 33
No Patient Involvement 33 33
Tissue Damage 29 29
Obstruction/Occlusion 23 23
Foreign Body Reaction 23 23
Swelling 22 22
Incontinence 22 22
Failure of Implant 21 21
Eye Injury 21 21
Urinary Tract Infection 20 20
Unspecified Tissue Injury 20 142
Sepsis 18 18
Fever 18 18
Discomfort 17 17
Impaired Healing 16 16
Erythema 16 16
Adhesion(s) 15 15
Fistula 15 15
Necrosis 14 14
Joint Dislocation 13 13
Vomiting 13 13
Loss of Range of Motion 12 12
Nerve Damage 12 12
High Blood Pressure/ Hypertension 11 11
Failure to Anastomose 11 11
Therapeutic Response, Decreased 11 11
Fibrosis 11 11
Fluid Discharge 10 10
Pericardial Effusion 9 9
Swelling/ Edema 9 9
Local Reaction 9 9
Abnormal Vaginal Discharge 9 9
Scar Tissue 8 8
Reaction 8 8
Bacterial Infection 8 8
Cellulitis 8 8
Abdominal Pain 8 8
Hypersensitivity/Allergic reaction 8 8
Pocket Erosion 7 7
Burning Sensation 7 7
Urinary Retention 7 7
Joint Laxity 7 7
Radiation Exposure, Unintended 7 7
Muscle/Tendon Damage 6 6
Unintended Radiation Exposure 6 6
Perforation 6 6
Laceration(s) 6 6
Muscular Rigidity 5 5
Irritation 5 5
Anemia 5 5
Dysphagia/ Odynophagia 5 5
Edema 5 5
Scarring 5 5
Visual Impairment 5 5
Urinary Frequency 4 4
Skin Irritation 4 4
Skin Discoloration 4 4
Endocarditis 4 4
Calcium Deposits/Calcification 4 4
Death 4 4
Airway Obstruction 4 4
Ischemia 4 4
Purulent Discharge 4 4
Foreign Body Sensation in Eye 4 4
Bone Fracture(s) 4 4
Itching Sensation 3 3
Cyst(s) 3 3
Thrombosis 3 3
Pneumonia 3 3
Internal Organ Perforation 3 3
Rupture 3 3
Eye Infections 3 3
Abdominal Distention 3 3
Pseudoaneurysm 2 2
Hematuria 2 2
Cardiac Perforation 2 2
Bowel Perforation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 ArthroCare Corporation II Sep-22-2020
2 Musculoskeletal Transplant Foundation, Inc. II Sep-20-2019
-
-