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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. (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

MDR Year MDR Reports MDR Events
2017 529 529
2018 356 356
2019 417 417
2020 460 460
2021 373 373
2022 324 324

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1483 1483
Appropriate Term/Code Not Available 418 418
Insufficient Information 173 173
Migration or Expulsion of Device 138 138
Patient Device Interaction Problem 134 134
Defective Device 81 81
Patient-Device Incompatibility 76 76
Migration 53 53
Degraded 34 34
Material Erosion 29 29
Material Split, Cut or Torn 28 28
Material Integrity Problem 26 26
Loss of or Failure to Bond 21 21
Break 21 21
Device Operates Differently Than Expected 19 19
Mechanics Altered 15 15
Material Perforation 14 14
Detachment of Device or Device Component 14 14
Material Deformation 12 12
Product Quality Problem 10 10
No Apparent Adverse Event 9 9
Contamination 8 8
Material Disintegration 8 8
Microbial Contamination of Device 7 7
Device Appears to Trigger Rejection 6 6
Device Contamination With Biological Material 5 5
Therapeutic or Diagnostic Output Failure 5 5
Material Fragmentation 4 4
Improper or Incorrect Procedure or Method 4 4
Entrapment of Device 4 4
Fluid/Blood Leak 3 3
Peeled/Delaminated 3 3
Off-Label Use 3 3
Leak/Splash 3 3
Split 3 3
Material Protrusion/Extrusion 3 3
Biocompatibility 3 3
Contamination /Decontamination Problem 2 2
Delamination 2 2
Difficult to Open or Close 2 2
Shelf Life Exceeded 2 2
Fitting Problem 2 2
Unexpected Therapeutic Results 2 2
Use of Device Problem 2 2
Fracture 2 2
Detachment Of Device Component 2 2
Failure To Adhere Or Bond 2 2
Air Leak 1 1
Calcified 1 1
Clumping in Device or Device Ingredient 1 1
Device Expiration Issue 1 1
Disconnection 1 1
Shipping Damage or Problem 1 1
Melted 1 1
Hole In Material 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Material Separation 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Extrusion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Malposition of Device 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Radiation Overexposure 1 1
Device Packaging Compromised 1 1
Torn Material 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 618 618
Injury 608 608
No Code Available 559 559
Pain 462 462
Unspecified Infection 430 430
Adhesion(s) 351 351
Seroma 214 214
Erosion 154 154
Abscess 152 152
Unspecified Tissue Injury 151 151
Impaired Healing 125 125
Obstruction/Occlusion 120 120
Fistula 113 114
Abdominal Pain 109 110
Necrosis 108 108
Inflammation 106 106
Not Applicable 106 106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 94 94
Bacterial Infection 88 88
Purulent Discharge 85 85
Failure of Implant 83 83
Insufficient Information 80 80
Wound Dehiscence 73 73
Fluid Discharge 65 65
Hematoma 64 64
Scar Tissue 62 62
Post Operative Wound Infection 60 60
Discharge 59 59
Abdominal Distention 56 56
Discomfort 53 53
Incontinence 49 49
Hemorrhage/Bleeding 45 45
Foreign Body Reaction 45 45
Sepsis 45 45
Nausea 45 45
Ascites 45 45
Fever 44 44
Urinary Tract Infection 40 40
No Consequences Or Impact To Patient 39 39
Scarring 39 39
Blood Loss 36 36
Vomiting 35 35
Erythema 31 31
Cellulitis 30 30
No Clinical Signs, Symptoms or Conditions 27 27
Fibrosis 26 26
No Known Impact Or Consequence To Patient 23 23
Prolapse 22 22
Swelling 22 22
Capsular Contracture 21 21
Hypersensitivity/Allergic reaction 20 20
Urinary Retention 20 20
Perforation 18 18
Disability 18 18
Bowel Perforation 18 18
Calcium Deposits/Calcification 17 17
Constipation 16 16
Diarrhea 15 15
Nerve Damage 15 15
Abnormal Vaginal Discharge 14 14
Emotional Changes 14 14
Ambulation Difficulties 14 14
No Information 13 13
Granuloma 13 13
Death 13 13
Swelling/ Edema 12 12
Fatigue 11 11
Dysphagia/ Odynophagia 10 10
Fungal Infection 10 10
Edema 9 9
Ischemia 9 9
Burning Sensation 9 9
Ulcer 9 9
Tachycardia 9 9
Staphylococcus Aureus 9 9
Muscle Weakness 8 8
Necrosis Of Flap Tissue 8 8
Peritonitis 8 8
Excessive Tear Production 8 8
Micturition Urgency 8 8
Respiratory Failure 8 8
Foreign Body In Patient 7 7
Urinary Frequency 7 7
Deformity/ Disfigurement 7 7
Depression 7 7
Complaint, Ill-Defined 6 6
Rash 6 6
Local Reaction 6 6
Renal Failure 6 6
Ulceration 6 6
Pocket Erosion 6 6
Failure to Anastomose 6 6
Anemia 6 6
Skin Inflammation/ Irritation 6 6
Patient Problem/Medical Problem 5 5
Device Embedded In Tissue or Plaque 5 5
Corneal Pannus 5 5
Headache 5 5
Eye Injury 5 5
Low Blood Pressure/ Hypotension 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
5 Stryker Leibinger GmbH & Co. KG II Mar-03-2022
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