TPLC - Total Product Life Cycle

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Device	plate, cranioplasty, preformed, alterable
Regulation Description	Preformed alterable cranioplasty plate.
Product Code	GWO
Regulation Number	882.5320
Device Class	2

Premarket Reviews
Manufacturer	Decision
3D SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MCI MEDICAL CONCEPT INNOVATION INC.
	SUBSTANTIALLY EQUIVALENT	1
OSTEONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	262	262
Inadequacy of Device Shape and/or Size	78	78
Adverse Event Without Identified Device or Use Problem	47	47
Device-Device Incompatibility	28	28
Entrapment of Device	15	15
Material Twisted/Bent	13	13
Migration	10	10
Failure to Cut	8	8
Difficult to Advance	5	5
Material Deformation	5	5
Device Appears to Trigger Rejection	4	4
Fitting Problem	3	3
Crack	3	3
Device Damaged Prior to Use	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Nonstandard Device	3	3
Peeled/Delaminated	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Fracture	2	2
Patient-Device Incompatibility	1	1
Application Program Version or Upgrade Problem	1	1
Contamination /Decontamination Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	357	357
Insufficient Information	44	44
Unspecified Infection	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Foreign Body In Patient	17	17
No Consequences Or Impact To Patient	8	8
Failure of Implant	6	6
No Known Impact Or Consequence To Patient	5	5
Cerebral Edema	5	5
Swelling/ Edema	4	4
Impaired Healing	3	3
Post Operative Wound Infection	3	3
Bacterial Infection	3	3
Bone Fracture(s)	2	2
Pain	2	2
Calcium Deposits/Calcification	2	2
Unspecified Tissue Injury	2	2
Wound Dehiscence	1	1
Inadequate Osseointegration	1	1
Necrosis	1	1
Implant Pain	1	1
Skin Erosion	1	1
Discomfort	1	1
Numbness	1	1
Ecchymosis	1	1
Visual Impairment	1	1
Non-union Bone Fracture	1	1
Cerebrospinal Fluid Leakage	1	1
Hemorrhage/Bleeding	1	1
Hypoesthesia	1	1
Deformity/ Disfigurement	1	1