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
KELYNIAM GLOBAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MCI MEDICAL CONCEPT INNOVATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSTEONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
TECHFIT DIGITAL SURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	372	372
Inadequacy of Device Shape and/or Size	88	88
Adverse Event Without Identified Device or Use Problem	45	45
Device-Device Incompatibility	27	27
Entrapment of Device	23	23
Nonstandard Device	16	16
Device Contaminated During Manufacture or Shipping	12	12
Migration	10	10
Difficult to Advance	9	9
Material Twisted/Bent	9	9
Failure to Cut	9	9
Crack	8	8
Fracture	6	6
Material Deformation	5	5
Fitting Problem	3	3
Device Damaged Prior to Use	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Loose or Intermittent Connection	3	3
Peeled/Delaminated	2	2
Device Fell	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Material Protrusion/Extrusion	2	2
Device Slipped	1	1
Accessory Incompatible	1	1
Patient-Device Incompatibility	1	1
Application Program Version or Upgrade Problem	1	1
Contamination /Decontamination Problem	1	1
Component Missing	1	1
Device Handling Problem	1	1
Failure to Advance	1	1
Device Appears to Trigger Rejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	516	516
Insufficient Information	57	57
Unspecified Infection	26	26
Foreign Body In Patient	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Failure of Implant	6	6
Cerebral Edema	5	5
Swelling/ Edema	4	4
Bacterial Infection	4	4
Impaired Healing	3	3
Unspecified Tissue Injury	2	2
Calcium Deposits/Calcification	2	2
Wound Dehiscence	1	1
Inadequate Osseointegration	1	1
Necrosis	1	1
Bone Fracture(s)	1	1
Post Operative Wound Infection	1	1
Foreign Body Reaction	1	1
Discomfort	1	1
Numbness	1	1
Ecchymosis	1	1
Pain	1	1
Non-union Bone Fracture	1	1
Cerebrospinal Fluid Leakage	1	1