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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
ACELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALAFAIR BIOSCIENCES INC
  SUBSTANTIALLY EQUIVALENT 3
AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY LIMITED (FORMERLY MESYNTHES LIMITED)
  SUBSTANTIALLY EQUIVALENT 1
AROA BIOSURGERY LTD.
  SUBSTANTIALLY EQUIVALENT 1
AZIYO BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
B. BRUAN SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
COLORADO THERAPEUTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 6
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. (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
TISGENX
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENIX GROUP PLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 508 508
2017 529 529
2018 356 356
2019 417 417
2020 460 460
2021 324 324

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1302 1302
Appropriate Term/Code Not Available 605 605
Insufficient Information 339 339
Migration or Expulsion of Device 146 146
Patient Device Interaction Problem 97 97
Defective Device 56 56
Patient-Device Incompatibility 56 56
Migration 44 44
Degraded 36 36
Material Erosion 30 30
Device Operates Differently Than Expected 29 29
Material Split, Cut or Torn 28 28
Material Integrity Problem 25 25
Loss of or Failure to Bond 21 21
Detachment of Device or Device Component 13 13
Material Perforation 13 13
Material Deformation 10 10
Product Quality Problem 10 10
Material Disintegration 9 9
Mechanics Altered 9 9
Microbial Contamination of Device 8 8
Break 8 8
Contamination 7 7
Therapeutic or Diagnostic Output Failure 7 7
Device Appears to Trigger Rejection 6 6
Improper or Incorrect Procedure or Method 5 5
No Apparent Adverse Event 5 5
Device Contamination With Biological Material 5 5
Detachment Of Device Component 4 4
Leak/Splash 4 4
Device Expiration Issue 4 4
Split 4 4
Torn Material 4 4
Device Dislodged or Dislocated 4 4
Fluid Leak 3 3
Shelf Life Exceeded 3 3
Entrapment of Device 3 3
Material Rupture 3 3
Biocompatibility 3 3
Material Protrusion/Extrusion 3 3
Material Fragmentation 3 3
Hole In Material 3 3
Device Emits Odor 2 2
Material Too Rigid or Stiff 2 2
Device Contamination with Chemical or Other Material 2 2
Unintended Movement 2 2
Fitting Problem 2 2
Flaked 2 2
Use of Device Problem 2 2
Delamination 2 2
Difficult to Open or Close 2 2
Failure To Adhere Or Bond 2 2
Fracture 2 2
Difficult to Remove 2 2
Human-Device Interface Problem 1 1
Calcified 1 1
Clumping in Device or Device Ingredient 1 1
Unexpected Therapeutic Results 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Radiation Overexposure 1 1
Melted 1 1
Shipping Damage or Problem 1 1
Contamination /Decontamination Problem 1 1
Extrusion 1 1
Disconnection 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Malposition of Device 1 1
Positioning Problem 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Peeled/Delaminated 1 1
Material Separation 1 1
Device Issue 1 1
Failure to Form Staple 1 1
Device Packaging Compromised 1 1
Expulsion 1 1
Human Factors Issue 1 1
Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 769 769
No Code Available 763 763
Pain 570 570
Hernia 463 463
Unspecified Infection 441 441
Adhesion(s) 348 348
Seroma 192 192
Erosion 149 149
Abscess 143 143
Unspecified Tissue Injury 127 127
Impaired Healing 118 118
Inflammation 112 112
Fistula 110 111
Abdominal Pain 110 111
Obstruction/Occlusion 109 109
Not Applicable 107 107
Necrosis 100 100
Failure of Implant 85 85
Purulent Discharge 83 83
Wound Dehiscence 68 68
Post Operative Wound Infection 60 60
Discharge 59 59
Bacterial Infection 57 57
Scar Tissue 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Hematoma 53 53
Abdominal Distention 52 52
Incontinence 51 51
Discomfort 51 51
Fluid Discharge 50 50
Ascites 45 45
Fever 45 45
Sepsis 44 44
Nausea 44 44
No Consequences Or Impact To Patient 43 43
Hemorrhage/Bleeding 41 41
Urinary Tract Infection 39 39
Scarring 39 39
Blood Loss 39 39
Foreign Body Reaction 38 38
Insufficient Information 37 37
Vomiting 35 35
No Known Impact Or Consequence To Patient 33 33
Cellulitis 27 27
Erythema 26 26
Fibrosis 25 25
Swelling 24 24
Capsular Contracture 21 21
Urinary Retention 20 20
Prolapse 20 20
Disability 18 18
Death 18 18
Hypersensitivity/Allergic reaction 17 17
No Information 17 17
Constipation 16 16
Ambulation Difficulties 16 16
Calcium Deposits/Calcification 16 16
Abnormal Vaginal Discharge 14 14
Nerve Damage 14 14
Bowel Perforation 14 14
Diarrhea 13 13
Granuloma 13 13
Perforation 12 12
Reaction 12 12
Respiratory Failure 10 10
Tachycardia 10 10
Staphylococcus Aureus 10 10
Ulceration 10 10
Edema 10 10
Fatigue 9 9
Ischemia 9 9
Failure to Anastomose 9 9
Burning Sensation 9 9
Complaint, Ill-Defined 9 9
Excessive Tear Production 9 9
Patient Problem/Medical Problem 9 9
Pocket Erosion 8 8
Necrosis Of Flap Tissue 8 8
Micturition Urgency 8 8
Emotional Changes 8 8
Dysphagia/ Odynophagia 8 8
Internal Organ Perforation 7 7
Ulcer 7 7
Urinary Frequency 7 7
Peritonitis 7 7
Cramp(s) 7 7
Foreign Body In Patient 7 7
No Patient Involvement 7 7
Fungal Infection 6 6
Depression 6 6
Stenosis 6 6
Renal Failure 6 6
Irritation 6 6
Anemia 6 6
Anaphylactic Shock 5 5
Corneal Pannus 5 5
Low Blood Pressure/ Hypotension 5 5
Headache 5 5
Eye Injury 5 5
Rash 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
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