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	2
MCI MEDICAL CONCEPT INNOVATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
OSTEONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER
	SUBSTANTIALLY EQUIVALENT	2
TECHFIT DIGITAL SURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	393	393
Inadequacy of Device Shape and/or Size	96	96
Adverse Event Without Identified Device or Use Problem	57	57
Device-Device Incompatibility	29	29
Entrapment of Device	23	23
Nonstandard Device	17	17
Material Twisted/Bent	16	16
Device Contaminated During Manufacture or Shipping	12	12
Migration	10	10
Crack	9	9
Difficult to Advance	9	9
Failure to Cut	9	9
Fracture	7	7
Material Deformation	6	6
Fitting Problem	4	4
Device Appears to Trigger Rejection	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
Patient-Device Incompatibility	2	2
Device Fell	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Component Missing	2	2
Material Protrusion/Extrusion	2	2
Device Slipped	1	1
Application Program Version or Upgrade Problem	1	1
Contamination /Decontamination Problem	1	1
Device Difficult to Maintain	1	1
Device Handling Problem	1	1
Failure to Advance	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	548	548
Insufficient Information	57	57
Unspecified Infection	33	33
Foreign Body In Patient	25	25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
No Consequences Or Impact To Patient	14	14
Failure of Implant	6	6
No Known Impact Or Consequence To Patient	5	5
Bacterial Infection	5	5
Cerebral Edema	5	5
Post Operative Wound Infection	4	4
Swelling/ Edema	4	4
Impaired Healing	3	3
Wound Dehiscence	2	2
Bone Fracture(s)	2	2
Pain	2	2
Calcium Deposits/Calcification	2	2
Unspecified Tissue Injury	2	2
Inadequate Osseointegration	1	1
No Code Available	1	1
Necrosis	1	1
No Information	1	1
Implant Pain	1	1
Foreign Body Reaction	1	1
Skin Erosion	1	1
Discomfort	1	1
Numbness	1	1
Ecchymosis	1	1
Visual Impairment	1	1
Abscess	1	1
Non-union Bone Fracture	1	1
Cerebrospinal Fluid Leakage	1	1
Hemorrhage/Bleeding	1	1
Hypoesthesia	1	1
Deformity/ Disfigurement	1	1