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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
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 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1681 1681
Patient Device Interaction Problem 160 160
Insufficient Information 148 148
Defective Device 101 101
Migration or Expulsion of Device 93 93
Break 89 89
Patient-Device Incompatibility 60 60
Migration 47 47
Material Integrity Problem 28 28
Degraded 27 27
Material Split, Cut or Torn 24 24
Mechanics Altered 21 21
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 Disintegration 11 11
Material Deformation 10 10
No Apparent Adverse Event 10 10
Appropriate Term/Code Not Available 8 8
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 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
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 902 902
Injury 434 434
Adhesion(s) 399 399
Unspecified Infection 361 361
Pain 360 360
Seroma 206 206
Unspecified Tissue Injury 205 205
Abscess 171 171
No Code Available 149 149
Obstruction/Occlusion 141 141
Insufficient Information 129 129
Fistula 129 129
Impaired Healing 127 127
No Clinical Signs, Symptoms or Conditions 126 126
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 124 124
Inflammation 118 118
Bacterial Infection 118 118
Necrosis 103 103
Abdominal Pain 101 101
Erosion 86 86
Purulent Discharge 83 83
Fluid Discharge 83 83
Failure of Implant 74 74
Wound Dehiscence 69 69
Scar Tissue 63 63
Hemorrhage/Bleeding 62 62
Abdominal Distention 58 58
Discomfort 53 53
Hematoma 51 51
Foreign Body Reaction 50 50
Discharge 49 49
Ascites 44 44
Post Operative Wound Infection 42 42
Fever 41 41
Nausea 40 40
Sepsis 40 40
Not Applicable 37 37
Incontinence 35 35
Erythema 34 34
Scarring 32 32
Vomiting 29 29
Cellulitis 29 29
Fibrosis 29 29
Urinary Tract Infection 28 28
Perforation 28 28
Swelling/ Edema 26 26
Hypersensitivity/Allergic reaction 24 24
Capsular Contracture 22 22
Emotional Changes 21 21
Blood Loss 18 18
Bowel Perforation 18 18
Prolapse 18 18
Constipation 17 17
Granuloma 17 17
Muscle Weakness 15 15
Diarrhea 13 13
Urinary Retention 13 13
No Consequences Or Impact To Patient 13 13
Disability 12 12
No Known Impact Or Consequence To Patient 12 12
Fungal Infection 11 11
Depression 11 11
Distress 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
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
Nodule 7 7
Staphylococcus Aureus 7 7
Nerve Damage 7 7
Ischemia 7 7
Low Blood Pressure/ Hypotension 6 6
Fatigue 6 6
Local Reaction 6 6
Pocket Erosion 6 6
Tachycardia 6 6
Chills 6 6
Dyspareunia 6 6
Dysuria 6 6
Foreign Body In Patient 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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