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
CEREMED , INC.
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	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	5
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	128	128
Adverse Event Without Identified Device or Use Problem	90	90
Inadequacy of Device Shape and/or Size	49	49
Device-Device Incompatibility	15	15
Material Twisted/Bent	11	11
Migration	9	9
Entrapment of Device	7	7
Insufficient Information	5	5
Material Deformation	5	5
Patient-Device Incompatibility	5	5
Fracture	4	4
Material Fragmentation	4	4
Nonstandard Device	4	4
Peeled/Delaminated	4	4
Device Appears to Trigger Rejection	4	4
Fitting Problem	3	3
Contamination	2	2
Crack	2	2
Migration or Expulsion of Device	2	2
Failure to Cut	2	2
Device Operates Differently Than Expected	2	2
Appropriate Term/Code Not Available	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Positioning Problem	1	1
Device Difficult to Maintain	1	1
Difficult to Advance	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination /Decontamination Problem	1	1
Detachment of Device or Device Component	1	1
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
Component Missing	1	1
Dull, Blunt	1	1
Material Separation	1	1
Difficult to Insert	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	144	144
Unspecified Infection	48	48
No Code Available	36	36
No Known Impact Or Consequence To Patient	36	36
No Consequences Or Impact To Patient	29	29
Insufficient Information	25	25
Hematoma	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Foreign Body In Patient	9	9
Failure of Implant	8	8
Post Operative Wound Infection	5	5
Impaired Healing	5	5
Cerebral Edema	4	4
Swelling/ Edema	4	4
Bacterial Infection	3	3
Necrosis	3	3
Pain	2	2
Inflammation	2	2
Seizures	2	2
Calcium Deposits/Calcification	2	2
Abscess	2	2
Unspecified Tissue Injury	2	2
Visual Impairment	2	2
No Information	2	2
Visual Disturbances	1	1
Reaction	1	1
Discomfort	1	1
Hypoesthesia	1	1
Deformity/ Disfigurement	1	1
Sedation	1	1
Implant Pain	1	1
Inadequate Osseointegration	1	1
Wound Dehiscence	1	1
Hemorrhage/Bleeding	1	1
Cerebrospinal Fluid Leakage	1	1
Purulent Discharge	1	1
Ecchymosis	1	1
Bone Fracture(s)	1	1
Skin Discoloration	1	1
Skin Erosion	1	1
Loss of Range of Motion	1	1
Staphylococcus Aureus	1	1