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TPLC
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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 Code
OWY
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
EMBODY, INC.
SUBSTANTIALLY EQUIVALENT
3
FIBRALIGN CORPORATION
SUBSTANTIALLY EQUIVALENT
1
1. K151083
BioBridge Collagen Matrix
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
Migration or Expulsion of Device
2
2
No Apparent Adverse Event
2
2
Material Deformation
2
2
Appropriate Term/Code Not Available
2
2
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Migration
1
1
Material Split, Cut or Torn
1
1
Failure to Eject
1
1
Mechanical Jam
1
1
Expulsion
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Degraded
1
1
Material Disintegration
1
1
Material Rupture
1
1
Material Separation
1
1
Inadequacy of Device Shape and/or Size
1
1
Unstable
1
1
Use of Device Problem
1
1
Defective Device
1
1
Connection Problem
1
1
Detachment of Device or Device Component
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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