TPLC - Total Product Life Cycle

show TPLC since

Device	plate, cranioplasty, preformed, alterable
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	3
STRYKER
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	126	126
Adverse Event Without Identified Device or Use Problem	53	53
Inadequacy of Device Shape and/or Size	51	51
Device-Device Incompatibility	15	15
Material Twisted/Bent	12	12
Entrapment of Device	11	11
Migration	10	10
Failure to Cut	7	7
Difficult to Advance	5	5
Material Deformation	5	5
Device Appears to Trigger Rejection	4	4
Crack	3	3
Nonstandard Device	3	3
Peeled/Delaminated	2	2
Device Damaged Prior to Use	2	2
Patient-Device Incompatibility	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Fitting Problem	1	1
Material Erosion	1	1
Contamination /Decontamination Problem	1	1
Component Missing	1	1
Device Difficult to Maintain	1	1
Fracture	1	1
Appropriate Term/Code Not Available	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	187	187
Insufficient Information	33	33
Unspecified Infection	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
No Consequences Or Impact To Patient	14	14
Foreign Body In Patient	13	13
Failure of Implant	6	6
No Known Impact Or Consequence To Patient	5	5
Post Operative Wound Infection	4	4
Swelling/ Edema	4	4
Bacterial Infection	4	4
Cerebral Edema	4	4
Impaired Healing	3	3
Pain	3	3
Wound Dehiscence	2	2
Calcium Deposits/Calcification	2	2
Unspecified Tissue Injury	2	2
Dry Mouth	1	1
Inadequate Osseointegration	1	1
No Code Available	1	1
Metal Related Pathology	1	1
Necrosis	1	1
No Information	1	1
Bone Fracture(s)	1	1
Implant Pain	1	1
Skin Erosion	1	1
Discomfort	1	1
Ecchymosis	1	1
Visual Impairment	1	1
Abscess	1	1
Cerebrospinal Fluid Leakage	1	1
Hemorrhage/Bleeding	1	1
Hypoesthesia	1	1
Deformity/ Disfigurement	1	1
Eye Pain	1	1