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	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	48	48
Delivered as Unsterile Product	20	20
Adverse Event Without Identified Device or Use Problem	18	140
Biocompatibility	14	14
Device Markings/Labelling Problem	7	7
Device Contaminated During Manufacture or Shipping	5	5
Appropriate Term/Code Not Available	4	4
Defective Device	3	247
Material Discolored	2	2
Improper or Incorrect Procedure or Method	2	2
Off-Label Use	1	1
Patient-Device Incompatibility	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
Component Missing	1	1
Material Deformation	1	1
Unexpected Therapeutic Results	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	72	72
Unspecified Infection	23	23
Insufficient Information	6	128
Cerebrospinal Fluid Leakage	5	249
Hemorrhage/Bleeding	5	5
Pain	4	4
Hearing Impairment	3	3
Inflammation	3	3
Swelling/ Edema	3	3
Skin Inflammation/ Irritation	2	2
Implant Pain	2	2
Paralysis	2	2
Bacterial Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Decreased Sensitivity	1	1
Solid Tumour	1	1
Failure of Implant	1	1
Cyst(s)	1	1
Adhesion(s)	1	1
Hematoma	1	1
Post Operative Wound Infection	1	1
Foreign Body Reaction	1	1
Unspecified Nervous System Problem	1	1
Visual Disturbances	1	1
Fever	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Nerve Damage	1	1
Osteolysis	1	1
Fluid Discharge	1	1
Abscess	1	1
Meningitis	1	1
Deformity/ Disfigurement	1	1
Fistula	1	1

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