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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
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
2019 416 416
2020 457 457
2021 369 369
2022 375 375
2023 485 485
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1616 1616
Patient Device Interaction Problem 157 157
Insufficient Information 142 142
Defective Device 98 98
Migration or Expulsion of Device 92 92
Break 89 89
Patient-Device Incompatibility 59 59
Migration 47 47
Material Integrity Problem 28 28
Degraded 27 27
Material Split, Cut or Torn 24 24
Mechanics Altered 20 20
Material Erosion 18 18
Peeled/Delaminated 16 16
Loss of or Failure to Bond 16 16
Material Perforation 13 13
Detachment of Device or Device Component 13 13
Material Deformation 10 10
No Apparent Adverse Event 8 8
Appropriate Term/Code Not Available 8 8
Tear, Rip or Hole in Device Packaging 7 7
Material Disintegration 7 7
Off-Label Use 6 6
Therapeutic or Diagnostic Output Failure 6 6
Contamination /Decontamination Problem 5 5
Fluid/Blood Leak 5 5
Product Quality Problem 5 5
Device Appears to Trigger Rejection 5 5
Improper or Incorrect Procedure or Method 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
Device Damaged Prior to Use 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 1 1
Malposition of Device 1 1
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
Material Rupture 1 1
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
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 851 851
Injury 434 434
Adhesion(s) 355 355
Pain 352 352
Unspecified Infection 342 342
Unspecified Tissue Injury 197 197
Seroma 186 186
Abscess 164 164
No Code Available 149 149
Insufficient Information 126 126
Obstruction/Occlusion 126 126
No Clinical Signs, Symptoms or Conditions 121 121
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 118 118
Fistula 118 118
Bacterial Infection 113 113
Impaired Healing 113 113
Inflammation 112 112
Necrosis 101 101
Abdominal Pain 97 97
Erosion 86 86
Purulent Discharge 79 79
Fluid Discharge 79 79
Failure of Implant 70 70
Wound Dehiscence 66 66
Scar Tissue 62 62
Hemorrhage/Bleeding 59 59
Abdominal Distention 56 56
Discomfort 52 52
Discharge 49 49
Hematoma 49 49
Foreign Body Reaction 49 49
Ascites 44 44
Sepsis 40 40
Fever 39 39
Nausea 39 39
Post Operative Wound Infection 37 37
Not Applicable 37 37
Incontinence 35 35
Erythema 34 34
Scarring 32 32
Cellulitis 29 29
Fibrosis 29 29
Vomiting 28 28
Perforation 27 27
Urinary Tract Infection 26 26
Swelling/ Edema 24 24
Hypersensitivity/Allergic reaction 23 23
Capsular Contracture 22 22
Emotional Changes 21 21
Bowel Perforation 18 18
Prolapse 18 18
Blood Loss 18 18
Granuloma 17 17
Constipation 16 16
Muscle Weakness 15 15
Urinary Retention 13 13
No Consequences Or Impact To Patient 13 13
Disability 12 12
Diarrhea 12 12
No Known Impact Or Consequence To Patient 12 12
Fungal Infection 11 11
Calcium Deposits/Calcification 11 11
Distress 11 11
Depression 10 10
Urinary Frequency 10 10
Abnormal Vaginal Discharge 10 10
Swelling 10 10
Dysphagia/ Odynophagia 10 10
Death 10 10
Micturition Urgency 10 10
Skin Inflammation/ Irritation 10 10
Edema 9 9
Anemia 8 8
Ulcer 8 8
Deformity/ Disfigurement 8 8
Device Embedded In Tissue or Plaque 8 8
Respiratory Failure 7 7
Ambulation Difficulties 7 7
Nodule 7 7
Staphylococcus Aureus 7 7
Nerve Damage 7 7
Ischemia 7 7
Low Blood Pressure/ Hypotension 6 6
Fatigue 6 6
Pocket Erosion 6 6
Local Reaction 6 6
Tachycardia 6 6
Chills 6 6
Thrombosis 5 5
Ulceration 5 5
Renal Failure 5 5
Excessive Tear Production 5 5
Peritonitis 5 5
Failure to Anastomose 5 5
Eye Injury 5 5
Dyspareunia 5 5
No Information 5 5
Foreign Body In Patient 5 5
Dysuria 5 5
Patient Problem/Medical Problem 4 4

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 Jan-05-2024
4 Baxter Healthcare Corporation II Jan-08-2021
5 Stryker Leibinger GmbH & Co. KG II Mar-03-2022
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