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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical
Product CodeFTM
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ACELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALAFAIR BIOSCIENCES INC
  SUBSTANTIALLY EQUIVALENT 3
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
AZIYO BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
B. BRUAN SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS LIFE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS LIFE TECHNOLOGIES, INC. (BAXTER INTERNATIONAL INC.)
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS LIFE TECHNOLOGIES. INC. (A SUBSIDIARY OF BAXTER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
TELA BIO
  SUBSTANTIALLY EQUIVALENT 1
TISGENX
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 356 356
2019 417 417
2020 460 460
2021 373 373
2022 377 377
2023 210 210

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1546 1546
Patient Device Interaction Problem 153 153
Insufficient Information 147 147
Migration or Expulsion of Device 116 116
Defective Device 94 94
Appropriate Term/Code Not Available 93 93
Break 83 83
Patient-Device Incompatibility 71 71
Migration 53 53
Degraded 33 33
Material Split, Cut or Torn 29 29
Material Integrity Problem 27 27
Material Erosion 27 27
Mechanics Altered 18 18
Loss of or Failure to Bond 17 17
Peeled/Delaminated 15 15
Material Perforation 14 14
Detachment of Device or Device Component 14 14
Material Deformation 9 9
No Apparent Adverse Event 9 9
Contamination 7 7
Material Disintegration 7 7
Product Quality Problem 7 7
Device Appears to Trigger Rejection 6 6
Therapeutic or Diagnostic Output Failure 5 5
Device Operates Differently Than Expected 4 4
Contamination /Decontamination Problem 4 4
Entrapment of Device 4 4
Improper or Incorrect Procedure or Method 4 4
Off-Label Use 3 3
Biocompatibility 3 3
Fluid/Blood Leak 3 3
Material Protrusion/Extrusion 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Open or Close 2 2
Fracture 2 2
Material Fragmentation 2 2
Leak/Splash 2 2
Shelf Life Exceeded 2 2
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Use of Device Problem 1 1
Malposition of Device 1 1
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Expiration Date Error 1 1
Melted 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Material Separation 1 1
Material Discolored 1 1
Disconnection 1 1
Failure To Adhere Or Bond 1 1
Calcified 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Extrusion 1 1
Material Twisted/Bent 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 707 707
Injury 568 568
Pain 424 424
Unspecified Infection 387 387
Adhesion(s) 337 337
No Code Available 212 212
Seroma 198 198
Unspecified Tissue Injury 172 172
Abscess 148 148
Erosion 127 127
Obstruction/Occlusion 124 124
Impaired Healing 121 121
Inflammation 115 115
Fistula 114 115
Insufficient Information 107 107
Abdominal Pain 105 106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 104 104
Necrosis 103 103
No Clinical Signs, Symptoms or Conditions 98 98
Not Applicable 90 90
Bacterial Infection 88 88
Purulent Discharge 86 86
Failure of Implant 80 80
Wound Dehiscence 69 69
Fluid Discharge 67 67
Scar Tissue 63 63
Abdominal Distention 56 56
Hematoma 55 55
Discharge 54 54
Hemorrhage/Bleeding 53 53
Discomfort 52 52
Incontinence 46 46
Post Operative Wound Infection 46 46
Foreign Body Reaction 45 45
Nausea 43 43
Ascites 43 43
Fever 42 42
Sepsis 42 42
Scarring 38 38
Urinary Tract Infection 38 38
Vomiting 33 33
Erythema 31 31
Cellulitis 29 29
Blood Loss 29 29
Perforation 27 27
Fibrosis 26 26
Prolapse 23 23
Capsular Contracture 21 21
Hypersensitivity/Allergic reaction 21 21
Urinary Retention 19 19
Swelling 19 19
Bowel Perforation 19 19
Swelling/ Edema 18 18
Emotional Changes 18 18
No Consequences Or Impact To Patient 17 17
Disability 17 17
Granuloma 16 16
No Known Impact Or Consequence To Patient 16 16
Constipation 16 16
Nerve Damage 15 15
Abnormal Vaginal Discharge 14 14
Diarrhea 14 14
Calcium Deposits/Calcification 14 14
Muscle Weakness 13 13
Death 11 11
Ambulation Difficulties 11 11
Fungal Infection 11 11
Dysphagia/ Odynophagia 10 10
Micturition Urgency 10 10
Deformity/ Disfigurement 10 10
Urinary Frequency 10 10
Ulcer 9 9
Depression 9 9
Tachycardia 9 9
Edema 9 9
No Information 9 9
Device Embedded In Tissue or Plaque 8 8
Fatigue 8 8
Ischemia 8 8
Excessive Tear Production 8 8
Staphylococcus Aureus 7 7
Anemia 7 7
Respiratory Failure 7 7
Foreign Body In Patient 7 7
Skin Inflammation/ Irritation 6 6
Local Reaction 6 6
Peritonitis 6 6
Chills 6 6
Burning Sensation 5 5
Pocket Erosion 5 5
Necrosis Of Flap Tissue 5 5
Internal Organ Perforation 5 5
Thrombosis 5 5
Ulceration 5 5
Corneal Pannus 5 5
Failure to Anastomose 5 5
Low Blood Pressure/ Hypotension 5 5
Eye Injury 5 5
Nodule 5 5
Dyspareunia 5 5

Recalls
Manufacturer Recall Class Date Posted
1 ACell, Inc II Mar-21-2019
2 AROA Biosurgery, LTD. II Nov-09-2018
3 AZIYO BIOLOGICS II Oct-04-2019
4 Baxter Healthcare Corporation II Jan-08-2021
5 Stryker Leibinger GmbH & Co. KG II Mar-03-2022
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