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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 205 205

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1415 1415
Appropriate Term/Code Not Available 418 418
Insufficient Information 167 167
Migration or Expulsion of Device 137 137
Patient Device Interaction Problem 120 120
Defective Device 73 73
Patient-Device Incompatibility 57 57
Migration 51 51
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
Device Operates Differently Than Expected 19 19
Break 14 14
Material Perforation 14 14
Detachment of Device or Device Component 14 14
Mechanics Altered 13 13
Material Deformation 12 12
Product Quality Problem 10 10
Microbial Contamination of Device 7 7
Device Appears to Trigger Rejection 6 6
Contamination 6 6
Material Disintegration 6 6
Device Contamination With Biological Material 5 5
Therapeutic or Diagnostic Output Failure 5 5
No Apparent Adverse Event 5 5
Improper or Incorrect Procedure or Method 4 4
Material Fragmentation 4 4
Off-Label Use 3 3
Leak/Splash 3 3
Peeled/Delaminated 3 3
Split 3 3
Fluid Leak 3 3
Entrapment of Device 3 3
Biocompatibility 3 3
Shelf Life Exceeded 2 2
Delamination 2 2
Difficult to Open or Close 2 2
Use of Device Problem 2 2
Failure To Adhere Or Bond 2 2
Fitting Problem 2 2
Detachment Of Device Component 2 2
Unexpected Therapeutic Results 2 2
Fracture 2 2
Material Protrusion/Extrusion 2 2
Hole In Material 1 1
Device Packaging Compromised 1 1
Expulsion 1 1
Air Leak 1 1
Calcified 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Radiation Overexposure 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Device Contamination with Body Fluid 1 1
Tear, Rip or Hole in Device Packaging 1 1
Clumping in Device or Device Ingredient 1 1
Noise, Audible 1 1
Device Dislodged or Dislocated 1 1
Torn Material 1 1
Shipping Damage or Problem 1 1
Melted 1 1
Device Expiration Issue 1 1
Contamination /Decontamination Problem 1 1
Extrusion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Disconnection 1 1
Material Rupture 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 608 608
Hernia 564 564
No Code Available 559 559
Pain 438 438
Unspecified Infection 420 420
Adhesion(s) 347 347
Seroma 202 202
Erosion 150 150
Abscess 146 146
Unspecified Tissue Injury 137 137
Impaired Healing 123 123
Obstruction/Occlusion 112 112
Fistula 109 110
Abdominal Pain 106 107
Necrosis 106 106
Not Applicable 106 106
Inflammation 98 98
Purulent Discharge 83 83
Failure of Implant 83 83
Bacterial Infection 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
Wound Dehiscence 66 66
Insufficient Information 66 66
Hematoma 59 59
Discharge 59 59
Fluid Discharge 56 56
Post Operative Wound Infection 56 56
Scar Tissue 55 55
Abdominal Distention 53 53
Discomfort 50 50
Incontinence 48 48
Ascites 44 44
Sepsis 44 44
Nausea 43 43
Foreign Body Reaction 42 42
Fever 42 42
No Consequences Or Impact To Patient 39 39
Scarring 39 39
Urinary Tract Infection 39 39
Hemorrhage/Bleeding 38 38
Blood Loss 36 36
Vomiting 34 34
Erythema 29 29
Cellulitis 28 28
Fibrosis 25 25
No Known Impact Or Consequence To Patient 23 23
Swelling 22 22
Prolapse 21 21
Capsular Contracture 21 21
No Clinical Signs, Symptoms or Conditions 19 19
Hypersensitivity/Allergic reaction 19 19
Urinary Retention 19 19
Disability 18 18
Constipation 16 16
Bowel Perforation 16 16
Calcium Deposits/Calcification 16 16
Perforation 15 15
Abnormal Vaginal Discharge 14 14
No Information 13 13
Death 13 13
Emotional Changes 13 13
Ambulation Difficulties 13 13
Granuloma 13 13
Diarrhea 13 13
Nerve Damage 13 13
Fatigue 10 10
Staphylococcus Aureus 9 9
Ischemia 9 9
Tachycardia 9 9
Edema 9 9
Necrosis Of Flap Tissue 8 8
Swelling/ Edema 8 8
Respiratory Failure 8 8
Burning Sensation 8 8
Ulcer 8 8
Excessive Tear Production 8 8
Deformity/ Disfigurement 7 7
Muscle Weakness 7 7
Dysphagia/ Odynophagia 7 7
Peritonitis 7 7
Urinary Frequency 7 7
Micturition Urgency 7 7
Local Reaction 6 6
Foreign Body In Patient 6 6
Ulceration 6 6
Renal Failure 6 6
Failure to Anastomose 6 6
Anemia 6 6
Fungal Infection 6 6
Complaint, Ill-Defined 6 6
Depression 6 6
Pocket Erosion 6 6
Headache 5 5
Eye Injury 5 5
Corneal Pannus 5 5
Rash 5 5
Low Blood Pressure/ Hypotension 5 5
Thrombosis 5 5
Cramp(s) 5 5
Patient Problem/Medical Problem 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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