TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
M/S. MERIL ENDO SURGERY PRIVATE LIMITED.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCON, INC.
	SUBSTANTIALLY EQUIVALENT	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	55	55
Delivered as Unsterile Product	23	23
Adverse Event Without Identified Device or Use Problem	17	17
Biocompatibility	14	14
Device Markings/Labelling Problem	7	7
Device Contaminated During Manufacture or Shipping	5	5
Appropriate Device Problem Term/Code Not Available	4	4
Off-Label Use	2	2
Material Discolored	2	2
Component Missing	2	2
Improper or Incorrect Procedure or Method	2	2
Patient-Device Incompatibility	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination /Decontamination Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Use of Device Problem	1	1
Fungus in Device Environment	1	1
Thickening of Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	83	83
Unspecified Infection	23	23
Insufficient Information	6	128
Hemorrhage/Blood Loss/Bleeding	5	5
Cerebrospinal Fluid Leakage	5	249
Pain	4	4
Hearing Impairment	3	3
Inflammation	3	3
Swelling/ Edema	3	3
Skin Inflammation/ Irritation	2	2
Implant Pain	2	2
Post Operative Wound Infection	2	2
Paralysis	2	2
Bacterial Infection	2	2
Solid Tumour	1	1
Failure of Implant	1	1
Adhesion(s)	1	1
Cyst(s)	1	1
Hematoma	1	1
Foreign Body Reaction	1	1
Unspecified Nervous System Problem	1	1
Colitis	1	1
Fever	1	1
Visual Disturbances	1	1
Foreign Body In Patient	1	1
Nerve Damage	1	1
Discomfort	1	1
Osteolysis	1	1
Hyporesponsive to stimuli	1	1
Abscess	1	1
Fluid Discharge	1	1
Deformity/ Disfigurement	1	1
Meningitis	1	1
Fistula	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Jan-05-2024