TPLC - Total Product Life Cycle

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Device	cement, bone, vertebroplasty
Regulation Description	Polymethylmethacrylate (PMMA) bone cement.
Product Code	NDN
Regulation Number	888.3027
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMBER IMPLANTS
	SUBSTANTIALLY EQUIVALENT	1
BIOPSYBELL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HYPREVENTION
	SUBSTANTIALLY EQUIVALENT	1
NINGBO HICREN BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SLK ORTHO, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	2
TECRES S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
XELITE BIOMED , LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Improper Chemical Reaction	320	320
Coagulation in Device or Device Ingredient	284	284
Inflation Problem	235	235
Fluid/Blood Leak	227	227
Leak/Splash	218	218
Adverse Event Without Identified Device or Use Problem	201	201
Material Integrity Problem	180	180
Failure to Eject	169	170
Migration or Expulsion of Device	128	129
Compatibility Problem	122	122
Chemical Problem	81	81
Break	72	72
Activation, Positioning or Separation Problem	46	46
Migration	46	46
Product Quality Problem	42	42
Fracture	25	32
Activation Failure	21	23
Device-Device Incompatibility	19	19
No Apparent Adverse Event	17	17
Insufficient Information	17	17
Entrapment of Device	16	16
Separation Failure	16	17
Difficult or Delayed Separation	15	19
Appropriate Term/Code Not Available	14	14
Patient Device Interaction Problem	9	9
Use of Device Problem	8	8
Device Damaged Prior to Use	8	8
Improper or Incorrect Procedure or Method	6	6
Pressure Problem	6	6
Mechanical Problem	6	6
Device Ingredient or Reagent Problem	5	5
Crack	5	5
Packaging Problem	5	5
Expiration Date Error	4	4
Detachment of Device or Device Component	4	4
Clumping in Device or Device Ingredient	4	4
Device Handling Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Nonstandard Device	3	3
Material Fragmentation	3	3
Tear, Rip or Hole in Device Packaging	3	3
Inaccurate Information	2	2
Off-Label Use	2	2
Device Emits Odor	2	2
Mechanics Altered	2	2
Excess Flow or Over-Infusion	2	2
Defective Device	2	2
Material Deformation	1	1
Material Rupture	1	1
Short Fill	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1609	1621
Insufficient Information	186	188
Extravasation	100	100
Bone Fracture(s)	46	46
Nerve Damage	40	40
Foreign Body In Patient	40	41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	39	39
Pain	37	37
Pulmonary Embolism	34	34
Unspecified Infection	32	32
Post Operative Wound Infection	29	29
Unspecified Tissue Injury	27	27
Osteolysis	26	26
Non-union Bone Fracture	22	22
Joint Laxity	21	21
Failure of Implant	18	18
Hematoma	17	17
Embolism/Embolus	17	17
Decreased Sensitivity	13	13
Cardiac Arrest	12	12
Dyspnea	11	11
Cerebrospinal Fluid Leakage	10	10
Vertebral Fracture	10	10
Perforation of Vessels	9	9
Spinal Cord Injury	9	9
Unspecified Nervous System Problem	8	8
Necrosis	8	8
Hemorrhage/Bleeding	6	6
Low Blood Pressure/ Hypotension	6	6
Physical Asymmetry	5	5
Swelling/ Edema	5	5
Neck Pain	5	5
Chest Pain	5	5
Impaired Healing	5	5
Stenosis	4	4
Dysphagia/ Odynophagia	4	4
Thrombosis/Thrombus	4	4
Fever	4	4
Hypersensitivity/Allergic reaction	4	4
Device Embedded In Tissue or Plaque	4	4
Discomfort	4	4
Ambulation Difficulties	4	4
Thromboembolism	3	3
Muscle Weakness	3	3
Inflammation	3	3
Hypoxia	3	3
Paraplegia	3	3
Cancer	3	3
Paralysis	3	3
Loss of Range of Motion	3	3