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 Code	OWY
Regulation Number	878.3300
Device Class	2

Premarket Reviews
Manufacturer	Decision
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	61	61
Insufficient Information	12	12
Break	10	10
Device Dislodged or Dislocated	6	6
Separation Problem	4	4
Material Fragmentation	3	3
Migration or Expulsion of Device	2	2
Material Deformation	2	2
Appropriate Term/Code Not Available	2	2
No Apparent Adverse Event	2	2
Material Split, Cut or Torn	1	1
Unstable	1	1
Expulsion	1	1
Failure to Eject	1	1
Material Disintegration	1	1
Patient Device Interaction Problem	1	1
Degraded	1	1
Use of Device Problem	1	1
Material Rupture	1	1
Connection Problem	1	1
Noise, Audible	1	1
Migration	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	32	32
No Clinical Signs, Symptoms or Conditions	22	22
Inflammation	17	17
Failure of Implant	15	15
Swelling/ Edema	11	11
Loss of Range of Motion	7	7
Unspecified Infection	6	6
Muscle/Tendon Damage	6	6
Foreign Body Reaction	6	6
Fluid Discharge	5	5
Adhesion(s)	5	5
Synovitis	5	5
No Known Impact Or Consequence To Patient	5	5
Device Embedded In Tissue or Plaque	4	4
Muscular Rigidity	4	4
Injury	4	4
Foreign Body In Patient	4	4
Rupture	4	4
Arthralgia	4	4
Skin Inflammation/ Irritation	3	3
Tissue Breakdown	3	3
Blister	2	2
Purulent Discharge	2	2
Cyst(s)	2	2
Erythema	2	2
Swelling	2	2
Insufficient Information	2	2
Scar Tissue	2	2
Fatigue	2	2
Unspecified Tissue Injury	2	2
Autoimmune Disorder	1	1
Ossification	1	1
Fever	1	1
Rash	1	1
Implant Pain	1	1
Discomfort	1	1
No Information	1	1
Hypersensitivity/Allergic reaction	1	1
Abscess	1	1
Capsular Contracture	1	1
Blurred Vision	1	1
Bacterial Infection	1	1
Fibrosis	1	1
Granuloma	1	1
Damage to Ligament(s)	1	1