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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 2
B. BRUAN SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ELUTIA INC.
  SUBSTANTIALLY EQUIVALENT 1
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
TELA BIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISGENX
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 416 416
2020 457 457
2021 369 369
2022 375 375
2023 486 486
2024 233 233

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1758 1758
Patient Device Interaction Problem 163 163
Insufficient Information 151 151
Defective Device 103 103
Migration or Expulsion of Device 93 93
Break 89 89
Patient-Device Incompatibility 61 61
Migration 48 48
Material Integrity Problem 28 28
Degraded 27 27
Material Split, Cut or Torn 25 25
Mechanics Altered 22 22
Material Erosion 18 18
Peeled/Delaminated 16 16
Loss of or Failure to Bond 16 16
Material Perforation 13 13
Material Disintegration 13 13
Detachment of Device or Device Component 13 13
Material Deformation 10 10
No Apparent Adverse Event 10 10
Appropriate Term/Code Not Available 9 9
Fluid/Blood Leak 8 8
Tear, Rip or Hole in Device Packaging 7 7
Off-Label Use 6 6
Therapeutic or Diagnostic Output Failure 6 6
Contamination /Decontamination Problem 5 5
Product Quality Problem 5 5
Device Appears to Trigger Rejection 5 5
Improper or Incorrect Procedure or Method 4 4
Compatibility Problem 4 4
Material Separation 3 3
Entrapment of Device 3 3
Leak/Splash 2 2
Material Discolored 2 2
Contamination 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Device Damaged Prior to Use 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Malposition of Device 2 2
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1
Separation Problem 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Expiration Date Error 1 1
Failure to Form Staple 1 1
Material Rupture 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Unexpected Therapeutic Results 1 1
Disconnection 1 1
Fracture 1 1
Material Fragmentation 1 1
Melted 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 975 975
Injury 434 434
Adhesion(s) 414 414
Unspecified Infection 373 373
Pain 364 364
Seroma 218 218
Unspecified Tissue Injury 215 215
Abscess 172 172
No Code Available 149 149
Obstruction/Occlusion 147 147
Fistula 134 134
Insufficient Information 133 133
Impaired Healing 129 129
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 128 128
No Clinical Signs, Symptoms or Conditions 128 128
Bacterial Infection 125 125
Inflammation 122 122
Necrosis 107 107
Abdominal Pain 102 102
Fluid Discharge 91 91
Erosion 87 87
Purulent Discharge 83 83
Failure of Implant 74 74
Wound Dehiscence 72 72
Scar Tissue 69 69
Hemorrhage/Bleeding 63 63
Abdominal Distention 59 59
Discomfort 55 55
Hematoma 52 52
Foreign Body Reaction 51 51
Discharge 49 49
Ascites 44 44
Post Operative Wound Infection 43 43
Fever 42 42
Nausea 40 40
Sepsis 40 40
Erythema 37 37
Not Applicable 37 37
Incontinence 35 35
Scarring 32 32
Cellulitis 30 30
Perforation 29 29
Vomiting 29 29
Swelling/ Edema 29 29
Fibrosis 29 29
Urinary Tract Infection 28 28
Emotional Changes 24 24
Hypersensitivity/Allergic reaction 24 24
Capsular Contracture 22 22
Blood Loss 18 18
Bowel Perforation 18 18
Prolapse 18 18
Constipation 17 17
Granuloma 17 17
Muscle Weakness 15 15
Depression 14 14
Distress 13 13
No Consequences Or Impact To Patient 13 13
Urinary Retention 13 13
Diarrhea 13 13
Disability 12 12
No Known Impact Or Consequence To Patient 12 12
Fungal Infection 11 11
Calcium Deposits/Calcification 11 11
Micturition Urgency 11 11
Dysphagia/ Odynophagia 10 10
Death 10 10
Urinary Frequency 10 10
Swelling 10 10
Abnormal Vaginal Discharge 10 10
Skin Inflammation/ Irritation 10 10
Nodule 10 10
Ambulation Difficulties 9 9
Edema 9 9
Anemia 8 8
Deformity/ Disfigurement 8 8
Ulcer 8 8
Device Embedded In Tissue or Plaque 8 8
Respiratory Failure 7 7
Staphylococcus Aureus 7 7
Fatigue 7 7
Nerve Damage 7 7
Ischemia 7 7
Low Blood Pressure/ Hypotension 6 6
Local Reaction 6 6
Pocket Erosion 6 6
Tachycardia 6 6
Chills 6 6
Foreign Body In Patient 6 6
Dysuria 6 6
Dyspareunia 6 6
No Information 5 5
Weight Changes 5 5
Excessive Tear Production 5 5
Peritonitis 5 5
Thrombosis 5 5
Ulceration 5 5
Renal Failure 5 5
High Blood Pressure/ Hypertension 5 5
Failure to Anastomose 5 5

Recalls
Manufacturer Recall Class Date Posted
1 ACell, Inc II Mar-21-2019
2 AZIYO BIOLOGICS II Oct-04-2019
3 Baxter Healthcare Corporation II Mar-26-2024
4 Baxter Healthcare Corporation II Jan-05-2024
5 Baxter Healthcare Corporation II Jan-08-2021
6 Stryker Leibinger GmbH & Co. KG II Mar-03-2022
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