TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CHENDU MEDART MEDICAL SCIENTIFIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEOS SURGERY S.L
	SUBSTANTIALLY EQUIVALENT	1
NEUROVENTION LLC
	SUBSTANTIALLY EQUIVALENT	1
OSSAWARE BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17	17
Break	12	12
Difficult to Open or Close	7	7
Insufficient Information	6	6
Device Appears to Trigger Rejection	6	6
Unstable	4	4
Unintended Movement	4	4
Patient Device Interaction Problem	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Human-Device Interface Problem	4	4
Compatibility Problem	2	2
Mechanics Altered	2	2
Product Quality Problem	2	2
Fracture	2	2
Nonstandard Device	2	2
Activation, Positioning or Separation Problem	1	1
Mechanical Problem	1	1
Output Problem	1	1
Patient-Device Incompatibility	1	1
Positioning Problem	1	1
Shipping Damage or Problem	1	1
Detachment of Device or Device Component	1	1
Appropriate Term/Code Not Available	1	1
Failure to Form Staple	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	44
Failure of Implant	4	4
Hematoma	4	4
Visual Impairment	3	3
Unspecified Infection	2	2
Patient Problem/Medical Problem	2	2
Skin Inflammation/ Irritation	2	2
Inflammation	2	2
Post Operative Wound Infection	2	2
No Known Impact Or Consequence To Patient	2	2
Insufficient Information	2	2
Fluid Discharge	2	2
Swelling/ Edema	2	2
Impaired Healing	1	1
Wound Dehiscence	1	1
Hypersensitivity/Allergic reaction	1	1
Hyperplasia	1	1
Swelling	1	1
Fall	1	1
Nodule	1	1
Erosion	1	1
No Consequences Or Impact To Patient	1	1
Granuloma	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Neuromodulation	II	Aug-06-2021