TPLC - Total Product Life Cycle

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Device	methyl methacrylate for cranioplasty
Product Code	GXP
Regulation Number	882.5300
Device Class	2

Premarket Reviews
Manufacturer	Decision
DIMENSIONAL BIOCERAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DOCTORS RESEARCH GROUP, INC.
	SE - WITH LIMITATIONS	1
ORTHOCON, INC.
	SUBSTANTIALLY EQUIVALENT	3
SKELETAL KINETICS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	61	61
Insufficient Information	14	14
Device Operates Differently Than Expected	9	9
Fracture	8	8
Break	6	6
Migration or Expulsion of Device	4	4
Crack	4	4
Migration	4	4
Device Operational Issue	3	3
Failure To Adhere Or Bond	3	3
Device Contamination with Chemical or Other Material	3	3
Loss of or Failure to Bond	3	3
Device Expiration Issue	2	2
Defective Component	2	2
Material Integrity Problem	2	2
Device Appears to Trigger Rejection	2	2
Fluid/Blood Leak	2	2
Fitting Problem	1	1
Chemical Problem	1	1
Compatibility Problem	1	1
Output Problem	1	1
Material Disintegration	1	1
Material Erosion	1	1
Defective Device	1	1
Positioning Problem	1	1
Contamination	1	1
Microbial Contamination of Device	1	1
Material Fragmentation	1	1
Difficult or Delayed Activation	1	1
Device Packaging Compromised	1	1
Detachment of Device or Device Component	1	1
Device Disinfection Or Sterilization Issue	1	1
Appropriate Term/Code Not Available	1	1
Coagulation in Device or Device Ingredient	1	1
Improper Chemical Reaction	1	1
Improper or Incorrect Procedure or Method	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Loss of Osseointegration	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	28	28
Unspecified Infection	22	22
No Code Available	21	21
Pain	21	21
Post Operative Wound Infection	16	16
Inflammation	14	14
Cerebrospinal Fluid Leakage	10	10
Impaired Healing	8	8
No Information	7	7
No Clinical Signs, Symptoms or Conditions	6	6
No Consequences Or Impact To Patient	5	5
Headache	5	5
Failure of Implant	5	5
Swelling/ Edema	4	4
Wound Dehiscence	3	3
Neurological Deficit/Dysfunction	3	3
Skin Inflammation	3	3
Swelling	3	3
Device Embedded In Tissue or Plaque	2	2
Pulmonary Embolism	2	2
Meningitis	2	2
Reaction	2	2
Visual Impairment	2	2
Disseminated Intravascular Coagulation (DIC)	2	2
Cardiopulmonary Arrest	2	2
Foreign Body In Patient	2	2
Staphylococcus Aureus	2	2
Dizziness	2	2
Inadequate Osseointegration	2	2
Death	2	2
Hearing Impairment	2	2
Vomiting	1	1
Numbness	1	1
Burning Sensation	1	1
Insufficient Information	1	1
Weakness	1	1
Post Traumatic Wound Infection	1	1
Autoimmune Disorder	1	1
Abscess	1	1
Nausea	1	1
Soreness	1	1
Tissue Damage	1	1
Facial Nerve Paralysis	1	1
Hearing Loss	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pocket Erosion	1	1
Neuropathy	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Doctor's Research Group, Inc.	II	May-08-2012
2	OSTEOPORE INTERNATIONAL PTE LTD	II	Jan-11-2012
3	Skeletal Kinetics, Llc	II	Jan-15-2021
4	Skeletal Kinetics, Llc	II	Jul-15-2020
5	Skeletal Kinetics, Llc	II	May-20-2020
6	Stryker Craniomaxillofacial Division	II	Aug-26-2013
7	Stryker Leibinger GmbH & Co. KG	II	Apr-19-2021
8	Synthes USA (HQ), Inc.	II	Nov-16-2009