TPLC - Total Product Life Cycle

show TPLC since

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	407	407
Inadequacy of Device Shape and/or Size	90	90
Adverse Event Without Identified Device or Use Problem	46	46
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
Crack	10	10
Difficult to Advance	10	10
Migration	10	10
Fracture	9	9
Material Deformation	5	5
Fitting Problem	4	4
Device Damaged Prior to Use	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Fragmentation	3	3
Loose or Intermittent Connection	3	3
Accessory Incompatible	2	2
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
Patient-Device Incompatibility	1	1
Application Program Version or Upgrade Problem	1	1
Difficult to Remove	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	593	593
Insufficient Information	58	58
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
Bacterial Infection	5	5
Cerebral Edema	5	5
Swelling/ Edema	4	4
Impaired Healing	3	3
Pain	2	2
Calcium Deposits/Calcification	2	2
Unspecified Tissue Injury	2	2
Wound Dehiscence	1	1
Nausea	1	1
Inadequate Osseointegration	1	1
Necrosis	1	1
Bone Fracture(s)	1	1
Foreign Body Reaction	1	1
Post Operative Wound Infection	1	1
Discomfort	1	1
Numbness	1	1
Ecchymosis	1	1
Non-union Bone Fracture	1	1
Cerebrospinal Fluid Leakage	1	1
Hot Flashes/Flushes	1	1