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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Improper Chemical Reaction	314	314
Coagulation in Device or Device Ingredient	265	265
Fluid/Blood Leak	222	222
Leak/Splash	209	209
Adverse Event Without Identified Device or Use Problem	199	199
Inflation Problem	198	198
Material Integrity Problem	174	174
Failure to Eject	161	162
Migration or Expulsion of Device	125	126
Compatibility Problem	88	88
Chemical Problem	78	78
Break	70	70
Migration	46	46
Product Quality Problem	31	31
Activation, Positioning or Separation Problem	23	23
Fracture	23	30
Activation Failure	21	23
Insufficient Information	17	17
Entrapment of Device	16	16
No Apparent Adverse Event	16	16
Device-Device Incompatibility	15	15
Difficult or Delayed Separation	15	19
Appropriate Term/Code Not Available	14	14
Separation Failure	14	15
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
Mechanical Problem	6	6
Device Ingredient or Reagent Problem	5	5
Pressure Problem	5	5
Packaging Problem	5	5
Expiration Date Error	4	4
Device Handling Problem	4	4
Clumping in Device or Device Ingredient	4	4
Detachment of Device or Device Component	4	4
Crack	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Material Fragmentation	3	3
Nonstandard Device	3	3
Tear, Rip or Hole in Device Packaging	3	3
Defective Device	2	2
Inaccurate Information	2	2
Excess Flow or Over-Infusion	2	2
Mechanics Altered	2	2
Off-Label Use	2	2
Osseointegration Problem	1	1
Mechanical Jam	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1497	1509
Insufficient Information	185	187
Extravasation	98	98
Bone Fracture(s)	46	46
Nerve Damage	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Pain	37	37
Foreign Body In Patient	36	37
Unspecified Infection	32	32
Pulmonary Embolism	32	32
Post Operative Wound Infection	29	29
Unspecified Tissue Injury	27	27
Osteolysis	26	26
Non-union Bone Fracture	21	21
Joint Laxity	21	21
Failure of Implant	18	18
Hematoma	17	17
Embolism/Embolus	17	17
Decreased Sensitivity	13	13
Cardiac Arrest	11	11
Dyspnea	10	10
Vertebral Fracture	10	10
Cerebrospinal Fluid Leakage	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
Neck Pain	5	5
Chest Pain	5	5
Impaired Healing	5	5
Swelling/ Edema	4	4
Stenosis	4	4
Fever	4	4
Thrombosis/Thrombus	4	4
Dysphagia/ Odynophagia	4	4
Hypersensitivity/Allergic reaction	4	4
Device Embedded In Tissue or Plaque	4	4
Hypoxia	3	3
Muscle Weakness	3	3
Inflammation	3	3
Paraplegia	3	3
Thromboembolism	3	3
Cancer	3	3
Paralysis	3	3
Loss of Range of Motion	3	3
Discomfort	3	3
Ambulation Difficulties	3	3