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	347	347
Coagulation in Device or Device Ingredient	322	322
Inflation Problem	268	268
Fluid/Blood Leak	251	251
Leak/Splash	246	246
Adverse Event Without Identified Device or Use Problem	211	211
Material Integrity Problem	208	208
Failure to Eject	184	185
Compatibility Problem	141	141
Migration or Expulsion of Device	137	138
Chemical Problem	88	88
Break	79	79
Product Quality Problem	54	54
Activation, Positioning or Separation Problem	54	54
Migration	48	48
Fracture	25	32
Device-Device Incompatibility	23	23
Activation Failure	22	25
Separation Failure	18	20
No Apparent Adverse Event	18	18
Insufficient Device Problem Information	17	17
Difficult or Delayed Separation	15	19
Entrapment of Device	15	15
Appropriate Device Problem Term/Code Not Available	14	14
Patient Device Interaction Problem	10	10
Use of Device Problem	8	8
Device Damaged Prior to Use	8	8
Mechanical Problem	7	7
Improper or Incorrect Procedure or Method	6	6
Pressure Problem	6	6
Device Ingredient or Reagent Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Crack	5	5
Packaging Problem	5	5
Expiration Date Error	4	4
Device Handling Problem	4	4
Clumping in Device or Device Ingredient	4	4
Nonstandard Device	4	4
Detachment of Device or Device Component	4	4
Tear, Rip or Hole in Device Packaging	3	3
Excess Flow or Over-Infusion	2	2
Mechanics Altered	2	2
Material Fragmentation	2	2
Defective Device	2	2
Inaccurate Information	2	2
Off-Label Use	2	2
Device Emits Odor	2	2
Contamination /Decontamination Problem	1	1
Positioning Problem	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1783	1797
Insufficient Information	196	198
Extravasation	113	113
Bone Fracture(s)	48	48
Foreign Body In Patient	42	43
Nerve Damage	41	41
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	40	40
Pain	39	39
Pulmonary Embolism	35	35
Unspecified Infection	33	33
Post Operative Wound Infection	30	30
Osteolysis	27	27
Unspecified Tissue Injury	27	27
Joint Laxity	22	22
Nonunion/Delayed-union Bone Fracture	22	22
Failure of Implant	18	18
Hematoma	17	17
Embolism/Embolus	17	17
Vertebral Fracture	14	14
Hyporesponsive to stimuli	13	13
Cardiac Arrest	12	12
Dyspnea	11	11
Spinal Cord Injury	10	10
Cerebrospinal Fluid Leakage	10	10
Perforation of Vessels	9	9
Necrosis	9	9
Hemorrhage/Blood Loss/Bleeding	8	8
Unspecified Nervous System Problem	8	8
Low Blood Pressure/ Hypotension	6	6
Hypoxia	6	6
Impaired Healing	5	5
Chest Pain	5	5
Swelling/ Edema	5	5
Dysphagia/ Odynophagia	5	5
Ambulation or Postural Difficulties	5	5
Physical Asymmetry	5	5
Neck Pain	5	5
Thrombosis/Thrombus	4	4
Hypersensitivity/Allergic reaction	4	4
Muscle Weakness/Atrophy	4	4
Device Embedded In Tissue or Plaque	4	4
Inflammation	4	4
Thromboembolism	4	4
Stenosis	4	4
Fever	4	4
Discomfort	4	4
Back pain	3	3
Cancer	3	3
Loss of Range of Motion	3	3
Paralysis	3	3