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
ALLIANCE PARTNERS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	1
CEREMED , INC.
	SUBSTANTIALLY EQUIVALENT	1
FOLSOM METAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
KELYNIAM GLOBAL INC.
	SUBSTANTIALLY EQUIVALENT	1
KINAMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	1
MCI MEDICAL CONCEPT INNOVATION INC.
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED L.P.
	SUBSTANTIALLY EQUIVALENT	1
OSTEONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
OSTEONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	10
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	160	160
Adverse Event Without Identified Device or Use Problem	105	105
Inadequacy of Device Shape and/or Size	54	54
Device-Device Incompatibility	16	16
Material Twisted/Bent	12	12
Entrapment of Device	11	11
Migration	10	10
Insufficient Information	9	9
Failure to Cut	7	7
Peeled/Delaminated	6	6
Fitting Problem	5	5
Material Deformation	5	5
Patient-Device Incompatibility	5	5
Difficult to Advance	5	5
Device Appears to Trigger Rejection	4	4
Nonstandard Device	4	4
Fracture	4	4
Device Operates Differently Than Expected	4	4
Material Fragmentation	4	4
Device Slipped	3	3
Appropriate Term/Code Not Available	3	3
Crack	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Contamination	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Device Damaged Prior to Use	2	2
Migration or Expulsion of Device	2	2
Malposition of Device	2	2
Component Missing	2	2
Positioning Problem	1	1
Contamination /Decontamination Problem	1	1
Defective Device	1	1
Failure To Adhere Or Bond	1	1
Material Erosion	1	1
Difficult to Insert	1	1
Failure to Osseointegrate	1	1
Bent	1	1
Detachment of Device or Device Component	1	1
Material Separation	1	1
Device Difficult to Maintain	1	1
Extrusion	1	1
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	187	187
Unspecified Infection	65	65
No Known Impact Or Consequence To Patient	43	43
No Code Available	37	37
Insufficient Information	33	33
No Consequences Or Impact To Patient	31	31
Hematoma	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Foreign Body In Patient	13	13
Failure of Implant	11	11
Post Operative Wound Infection	6	6
Impaired Healing	5	5
Cerebral Edema	4	4
Bacterial Infection	4	4
Swelling/ Edema	4	4
Inflammation	4	4
Pain	4	4
Necrosis	3	3
Tissue Breakdown	2	2
Unspecified Tissue Injury	2	2
Calcium Deposits/Calcification	2	2
Reaction	2	2
Abscess	2	2
Visual Impairment	2	2
Visual Disturbances	2	2
No Information	2	2
Seizures	2	2
Wound Dehiscence	2	2
Loss of Range of Motion	1	1
Swelling	1	1
Discomfort	1	1
No Patient Involvement	1	1
Skin Erosion	1	1
Ecchymosis	1	1
Skin Discoloration	1	1
Staphylococcus Aureus	1	1
Purulent Discharge	1	1
Sedation	1	1
Implant Pain	1	1
Fluid Discharge	1	1
Bone Fracture(s)	1	1
Non-union Bone Fracture	1	1
Metal Related Pathology	1	1
Cerebrospinal Fluid Leakage	1	1
Tissue Damage	1	1
Inadequate Osseointegration	1	1
Erosion	1	1
Hemorrhage/Bleeding	1	1
Hypoesthesia	1	1
Deformity/ Disfigurement	1	1