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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 4
ARTHREX, INC
  SUBSTANTIALLY EQUIVALENT 1
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 1173 1173

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1334 1334
Firing Problem 918 918
Failure to Fire 832 832
Adverse Event Without Identified Device or Use Problem 709 709
Activation, Positioning or Separation Problem 574 574
Premature Activation 545 545
Material Separation 448 448
Positioning Failure 363 363
Device Dislodged or Dislocated 282 282
Detachment of Device or Device Component 247 247
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 70 70
Material Split, Cut or Torn 67 67
Loose or Intermittent Connection 62 62
Component Falling 56 56
Activation Problem 56 56
Material Twisted/Bent 54 54
Device Fell 52 52
Failure to Advance 49 49
Mechanical Problem 43 43
Material Frayed 42 42
Patient-Device Incompatibility 39 39
Physical Resistance/Sticking 38 38
Component Missing 36 36
Mechanical Jam 32 32
Migration or Expulsion of Device 29 29
Device Slipped 28 28
Unstable 28 28
Use of Device Problem 26 26
Crack 25 25
Material Integrity Problem 25 25
Device Markings/Labelling Problem 25 25
Packaging Problem 21 21
Migration 20 20
Positioning Problem 19 19
Patient Device Interaction Problem 19 19
Manufacturing, Packaging or Shipping Problem 19 19
Material Deformation 19 19
Biocompatibility 19 19
Tear, Rip or Hole in Device Packaging 18 18
Unraveled Material 18 18
Nonstandard Device 18 18
Difficult to Remove 18 18
Retraction Problem 17 17
Difficult to Insert 17 17
Therapeutic or Diagnostic Output Failure 17 17
Failure to Cycle 15 15
Component Misassembled 15 15
Ejection Problem 15 15
Material Fragmentation 14 14
Product Quality Problem 14 14
Unsealed Device Packaging 14 14
Sticking 14 14
Entrapment of Device 13 13
Activation Failure 13 13
Output Problem 12 12
Delivered as Unsterile Product 12 12
Device Inoperable 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Defective Component 11 11
Malposition of Device 10 10
Contamination /Decontamination Problem 9 9
Dull, Blunt 9 9
No Apparent Adverse Event 9 9
Component Incompatible 9 9
Disconnection 8 8
Device Contamination with Chemical or Other Material 8 8
Expulsion 8 8
Expiration Date Error 8 8
Separation Failure 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Material Protrusion/Extrusion 7 7
Fracture 7 7
Bent 7 7
Improper or Incorrect Procedure or Method 7 7
Material Rupture 7 7
Separation Problem 7 7
Peeled/Delaminated 6 6
Contamination 6 6
Device Contaminated During Manufacture or Shipping 6 6
Failure to Align 6 6
Physical Resistance 5 5
Defective Device 5 5
Human-Device Interface Problem 5 5
Unintended Movement 5 5
Noise, Audible 5 5
Material Erosion 5 5
Partial Blockage 4 4
Device Damaged Prior to Use 4 4
Connection Problem 4 4
Difficult to Advance 4 4
Difficult to Open or Close 4 4
Split 4 4
Mechanics Altered 3 3
Device-Device Incompatibility 3 3
Difficult To Position 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 2448 2448
No Consequences Or Impact To Patient 855 855
No Information 344 344
Not Applicable 267 267
No Code Available 202 202
Unspecified Infection 180 180
Insufficient Information 154 154
Pain 153 153
Foreign Body In Patient 136 136
Injury 115 115
Device Embedded In Tissue or Plaque 67 67
Inflammation 62 62
Post Operative Wound Infection 60 60
Hernia 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 52 52
Wound Dehiscence 50 50
Erosion 46 46
Hemorrhage/Bleeding 46 46
Blood Loss 46 46
Hematoma 42 42
Abscess 41 41
Granuloma 38 38
Seroma 33 33
No Patient Involvement 33 33
Unspecified Tissue Injury 33 155
Tissue Damage 29 29
Obstruction/Occlusion 26 26
Incontinence 24 24
Failure of Implant 24 24
Foreign Body Reaction 23 23
Urinary Tract Infection 22 22
Swelling 22 22
Eye Injury 21 21
Fever 20 20
Impaired Healing 19 19
Sepsis 18 18
Discomfort 17 17
Erythema 17 17
Adhesion(s) 16 16
Necrosis 16 16
Joint Dislocation 15 15
Fistula 15 15
Failure to Anastomose 14 14
Vomiting 14 14
Nerve Damage 14 14
Fluid Discharge 14 14
Swelling/ Edema 14 14
Fibrosis 13 13
Loss of Range of Motion 12 12
Therapeutic Response, Decreased 11 11
Abdominal Pain 11 11
High Blood Pressure/ Hypertension 11 11
Laceration(s) 10 10
Bacterial Infection 10 10
Scar Tissue 10 10
Pocket Erosion 9 9
Abnormal Vaginal Discharge 9 9
Local Reaction 9 9
Cellulitis 9 9
Hypersensitivity/Allergic reaction 9 9
Pericardial Effusion 9 9
Urinary Retention 8 8
Reaction 8 8
Burning Sensation 7 7
Purulent Discharge 7 7
Joint Laxity 7 7
Unintended Radiation Exposure 7 7
Muscle/Tendon Damage 7 7
Radiation Exposure, Unintended 7 7
Dysphagia/ Odynophagia 6 6
Perforation 6 6
Scarring 5 5
Rupture 5 5
Visual Impairment 5 5
Urinary Frequency 5 5
Edema 5 5
Anemia 5 5
Muscular Rigidity 5 5
Nausea 5 5
Irritation 5 5
Thrombosis/Thrombus 5 5
Ischemia 4 4
Foreign Body Sensation in Eye 4 4
Bone Fracture(s) 4 4
Airway Obstruction 4 4
Endocarditis 4 4
Calcium Deposits/Calcification 4 4
Death 4 4
Skin Discoloration 4 4
Skin Irritation 4 4
Thrombosis 3 3
Pneumonia 3 3
Internal Organ Perforation 3 3
Non-union Bone Fracture 3 3
Cyst(s) 3 3
Micturition Urgency 3 3
Pyrosis/Heartburn 3 3
Itching Sensation 3 3
Abdominal Distention 3 3

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