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	27	27
Break	14	14
Difficult to Open or Close	10	10
Unstable	9	9
Insufficient Information	8	8
Device Appears to Trigger Rejection	7	7
Human-Device Interface Problem	4	4
Unintended Movement	4	4
Patient Device Interaction Problem	4	4
Appropriate Term/Code Not Available	3	3
Detachment of Device or Device Component	2	2
Compatibility Problem	2	2
Mechanics Altered	2	2
Fracture	2	2
Nonstandard Device	2	2
Product Quality Problem	2	2
Mechanical Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Failure to Form Staple	1	1
Patient-Device Incompatibility	1	1
Activation, Positioning or Separation Problem	1	1
Material Separation	1	1
Shipping Damage or Problem	1	1
Output Problem	1	1
Positioning Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
No Known Impact Or Consequence To Patient	19	19
Unspecified Infection	7	7
Post Operative Wound Infection	6	6
Hematoma	4	4
Visual Impairment	3	3
Patient Problem/Medical Problem	2	2
Skin Inflammation/ Irritation	2	2
Inflammation	2	2
Discomfort	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
Failure of Implant	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