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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 2
ALAFAIR BIOSCIENCES INC
  SUBSTANTIALLY EQUIVALENT 3
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
AZIYO BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
B. BRUAN SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
COLORADO THERAPEUTICS LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
CURASEAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 1
LIFECELL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MIROMATRIX MEDICAL INC.
  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
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
TELA BIO
  SUBSTANTIALLY EQUIVALENT 1
TELA BIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISGENX
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 529 529
2018 356 356
2019 416 416
2020 457 457
2021 369 369
2022 375 375
2023 485 485
2024 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1962 1962
Appropriate Term/Code Not Available 421 421
Insufficient Information 207 207
Patient Device Interaction Problem 173 173
Migration or Expulsion of Device 142 142
Defective Device 105 105
Break 90 90
Patient-Device Incompatibility 77 77
Migration 55 55
Degraded 38 38
Material Erosion 29 29
Material Integrity Problem 29 29
Material Split, Cut or Torn 29 29
Mechanics Altered 26 26
Loss of or Failure to Bond 21 21
Device Operates Differently Than Expected 19 19
Peeled/Delaminated 17 17
Detachment of Device or Device Component 14 14
Material Deformation 14 14
Material Perforation 14 14
Material Disintegration 13 13
No Apparent Adverse Event 13 13
Product Quality Problem 10 10
Fluid/Blood Leak 9 9
Contamination 8 8
Tear, Rip or Hole in Device Packaging 8 8
Microbial Contamination of Device 7 7
Device Appears to Trigger Rejection 6 6
Off-Label Use 6 6
Therapeutic or Diagnostic Output Failure 6 6
Contamination /Decontamination Problem 5 5
Device Contamination With Biological Material 5 5
Compatibility Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Material Fragmentation 4 4
Entrapment of Device 4 4
Leak/Splash 3 3
Material Separation 3 3
Biocompatibility 3 3
Split 3 3
Use of Device Problem 3 3
Material Protrusion/Extrusion 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Open or Close 2 2
Delamination 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Shelf Life Exceeded 2 2
Unexpected Therapeutic Results 2 2
Material Too Rigid or Stiff 2 2
Fracture 2 2
Detachment Of Device Component 2 2
Material Discolored 2 2
Failure To Adhere Or Bond 2 2
Air Leak 1 1
Calcified 1 1
Clumping in Device or Device Ingredient 1 1
Disconnection 1 1
Hole In Material 1 1
Device Expiration Issue 1 1
Material Rupture 1 1
Material Puncture/Hole 1 1
Melted 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Expiration Date Error 1 1
Failure to Form Staple 1 1
Malposition of Device 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Device Packaging Compromised 1 1
Material Twisted/Bent 1 1
Radiation Overexposure 1 1
Torn Material 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 1006 1006
Injury 607 607
No Code Available 559 559
Pain 505 505
Unspecified Infection 488 488
Adhesion(s) 472 472
Seroma 274 274
Unspecified Tissue Injury 214 214
Abscess 199 199
Obstruction/Occlusion 169 169
Erosion 160 160
Fistula 153 154
Impaired Healing 151 151
Inflammation 137 137
Bacterial Infection 137 137
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 131 131
Insufficient Information 129 129
Abdominal Pain 129 130
No Clinical Signs, Symptoms or Conditions 126 126
Necrosis 123 123
Not Applicable 106 106
Purulent Discharge 98 98
Fluid Discharge 90 90
Failure of Implant 89 89
Wound Dehiscence 87 87
Hematoma 76 76
Scar Tissue 74 74
Post Operative Wound Infection 72 72
Hemorrhage/Bleeding 68 68
Abdominal Distention 67 67
Discomfort 64 64
Discharge 59 59
Foreign Body Reaction 53 53
Incontinence 53 53
Nausea 52 52
Fever 51 51
Ascites 50 50
Sepsis 48 48
Urinary Tract Infection 45 45
Vomiting 41 41
Scarring 39 39
Erythema 39 39
No Consequences Or Impact To Patient 39 39
Cellulitis 36 36
Blood Loss 36 36
Perforation 32 32
Fibrosis 31 31
Capsular Contracture 28 28
Swelling/ Edema 27 27
Hypersensitivity/Allergic reaction 25 25
Prolapse 25 25
Constipation 24 24
Urinary Retention 23 23
No Known Impact Or Consequence To Patient 23 23
Emotional Changes 22 22
Swelling 22 22
Bowel Perforation 20 20
Ambulation Difficulties 19 19
Disability 18 18
Nerve Damage 17 17
Granuloma 17 17
Diarrhea 17 17
Calcium Deposits/Calcification 16 16
Muscle Weakness 15 15
Abnormal Vaginal Discharge 14 14
Depression 14 14
No Information 13 13
Death 13 13
Fatigue 12 12
Distress 12 12
Fungal Infection 11 11
Dysphagia/ Odynophagia 11 11
Micturition Urgency 11 11
Skin Inflammation/ Irritation 10 10
Urinary Frequency 10 10
Ulcer 10 10
Deformity/ Disfigurement 10 10
Tachycardia 10 10
Burning Sensation 9 9
Ischemia 9 9
Respiratory Failure 9 9
Edema 9 9
Staphylococcus Aureus 9 9
Device Embedded In Tissue or Plaque 8 8
Peritonitis 8 8
Excessive Tear Production 8 8
Anemia 8 8
Necrosis Of Flap Tissue 8 8
Foreign Body In Patient 8 8
Chills 7 7
Pocket Erosion 7 7
Dysuria 7 7
Renal Failure 7 7
Nodule 7 7
Headache 6 6
Dyspareunia 6 6
Rash 6 6
Ulceration 6 6
Low Blood Pressure/ Hypotension 6 6
Local Reaction 6 6

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 Mar-26-2024
5 Baxter Healthcare Corporation II Jan-05-2024
6 Baxter Healthcare Corporation II Jan-08-2021
7 Stryker Leibinger GmbH & Co. KG II Mar-03-2022
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