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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, collagen, orthopaedics, reinforcement of tendon
Definition For reinforcement of soft tissue where weakness exists in tendon repair.
Product CodeOWY
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
EMBODY, INC.
  SUBSTANTIALLY EQUIVALENT 3
FIBRALIGN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MUSCULOSKELETAL TRANSPLANT FOUNDATION
  SUBSTANTIALLY EQUIVALENT 1
ROTATION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 14 14
2021 25 25
2022 14 14
2023 35 35
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 57 57
Insufficient Information 12 12
Break 7 7
Device Dislodged or Dislocated 6 6
Separation Problem 4 4
Material Fragmentation 3 3
Material Deformation 2 2
Appropriate Term/Code Not Available 2 2
No Apparent Adverse Event 2 2
Migration or Expulsion of Device 2 2
Material Disintegration 1 1
Migration 1 1
Unstable 1 1
Use of Device Problem 1 1
Degraded 1 1
Failure to Eject 1 1
Material Split, Cut or Torn 1 1
Connection Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Expulsion 1 1
Patient Device Interaction Problem 1 1
Mechanical Jam 1 1
Material Separation 1 1
Noise, Audible 1 1
Detachment of Device or Device Component 1 1
Defective Device 1 1
Material Rupture 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 30 30
No Clinical Signs, Symptoms or Conditions 19 19
Inflammation 16 16
Failure of Implant 15 15
Swelling/ Edema 8 8
Loss of Range of Motion 7 7
Unspecified Infection 6 6
Muscle/Tendon Damage 6 6
No Known Impact Or Consequence To Patient 5 5
Adhesion(s) 5 5
Foreign Body Reaction 5 5
Muscular Rigidity 4 4
Device Embedded In Tissue or Plaque 4 4
Fluid Discharge 4 4
Foreign Body In Patient 4 4
Rupture 4 4
Injury 4 4
Arthralgia 4 4
Tissue Breakdown 3 3
Synovitis 3 3
Skin Inflammation/ Irritation 3 3
Scar Tissue 2 2
Swelling 2 2
Blister 2 2
Cyst(s) 2 2
Purulent Discharge 2 2
Erythema 2 2
Fatigue 2 2
Fever 1 1
Granuloma 1 1
Hypersensitivity/Allergic reaction 1 1
Autoimmune Disorder 1 1
Capsular Contracture 1 1
Ossification 1 1
Rash 1 1
Damage to Ligament(s) 1 1
Fibrosis 1 1
No Information 1 1
Blurred Vision 1 1
Unspecified Tissue Injury 1 1
Implant Pain 1 1
Insufficient Information 1 1

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