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	425	425
Inadequacy of Device Shape and/or Size	94	94
Adverse Event Without Identified Device or Use Problem	44	44
Failure to Cut	37	37
Device-Device Incompatibility	28	28
Entrapment of Device	23	23
Nonstandard Device	17	17
Device Contaminated During Manufacture or Shipping	12	12
Material Twisted/Bent	11	11
Difficult to Advance	10	10
Migration	10	10
Crack	10	10
Fracture	9	9
Material Deformation	5	5
Fitting Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Material Fragmentation	3	3
Device Damaged Prior to Use	3	3
Device Fell	2	2
Accessory Incompatible	2	2
Loose or Intermittent Connection	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Peeled/Delaminated	2	2
Material Protrusion/Extrusion	2	2
Contamination /Decontamination Problem	1	1
Device Slipped	1	1
Application Program Version or Upgrade Problem	1	1
Device Handling Problem	1	1
Component Missing	1	1
Failure to Advance	1	1
Patient-Device Incompatibility	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	615	615
Insufficient Information	59	59
Unspecified Infection	26	26
Foreign Body In Patient	24	24
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	17	17
Failure of Implant	6	6
Bacterial Infection	5	5
Cerebral Edema	5	5
Pain	4	4
Swelling/ Edema	4	4
Impaired Healing	3	3
Calcium Deposits/Calcification	2	2
Loss of Range of Motion	2	2
Unspecified Tissue Injury	2	2
Ecchymosis	1	1
Inadequate Osseointegration	1	1
Discomfort	1	1
Foreign Body Reaction	1	1
Necrosis	1	1
Post Operative Wound Infection	1	1
Wound Dehiscence	1	1
Hot Flashes/Flushes	1	1
Nonunion/Delayed-union Bone Fracture	1	1
Nausea	1	1
Cerebrospinal Fluid Leakage	1	1
Bone Fracture(s)	1	1
Numbness	1	1