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
BIOPSYBELL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
HYPREVENTION
	SUBSTANTIALLY EQUIVALENT	1
HYPREVENTION SAS
	SUBSTANTIALLY EQUIVALENT	1
JOLINE GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
NINGBO HICREN BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SLK ORTHO LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	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	287	287
Adverse Event Without Identified Device or Use Problem	224	224
Fluid/Blood Leak	180	180
Leak/Splash	151	151
Migration or Expulsion of Device	146	146
Material Integrity Problem	142	142
Failure to Eject	134	134
Inflation Problem	119	119
Chemical Problem	116	116
Coagulation in Device or Device Ingredient	110	110
Migration	58	58
Break	56	56
Compatibility Problem	33	33
Fracture	20	23
No Apparent Adverse Event	18	18
Insufficient Information	17	17
Product Quality Problem	17	17
Appropriate Term/Code Not Available	16	16
Entrapment of Device	15	15
Activation Failure	13	15
Activation, Positioning or Separation Problem	12	12
Separation Failure	12	13
Difficult or Delayed Separation	12	16
Packaging Problem	12	12
Patient Device Interaction Problem	9	9
Device-Device Incompatibility	7	7
Mechanical Problem	6	6
Improper or Incorrect Procedure or Method	5	5
Crack	5	5
Device Damaged Prior to Use	5	5
Clumping in Device or Device Ingredient	5	5
Device Ingredient or Reagent Problem	4	4
Device Handling Problem	4	4
Expiration Date Error	3	3
Detachment of Device or Device Component	3	3
Tear, Rip or Hole in Device Packaging	3	3
Inaccurate Information	2	2
Nonstandard Device	2	2
Material Separation	2	2
Mechanics Altered	2	2
Excess Flow or Over-Infusion	2	2
Use of Device Problem	2	2
Material Fragmentation	2	2
Contamination /Decontamination Problem	2	2
Defective Device	2	2
Pressure Problem	2	2
Problem with Sterilization	1	1
Device Difficult to Setup or Prepare	1	1
Use of Incorrect Control/Treatment Settings	1	1
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1064	1071
Insufficient Information	164	166
Extravasation	112	112
No Consequences Or Impact To Patient	59	59
Bone Fracture(s)	59	59
Pain	54	54
Nerve Damage	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
No Code Available	35	35
Foreign Body In Patient	34	34
Pulmonary Embolism	32	32
Unspecified Infection	31	31
Unspecified Tissue Injury	28	28
No Known Impact Or Consequence To Patient	27	27
Osteolysis	26	26
Post Operative Wound Infection	26	26
Failure of Implant	23	23
Hematoma	23	23
Non-union Bone Fracture	21	21
Joint Laxity	21	21
Injury	15	15
Embolism/Embolus	15	15
Decreased Sensitivity	13	13
Cardiac Arrest	12	12
Cerebrospinal Fluid Leakage	11	11
Necrosis	10	10
Perforation of Vessels	9	9
Dyspnea	9	9
Vertebral Fracture	9	9
Spinal Cord Injury	8	8
Unspecified Nervous System Problem	7	7
Impaired Healing	7	7
Chest Pain	6	6
Physical Asymmetry	5	5
Stenosis	5	5
Hypersensitivity/Allergic reaction	5	5
Neck Pain	5	5
Inflammation	4	4
Swelling/ Edema	4	4
Dysphagia/ Odynophagia	4	4
Death	4	4
No Patient Involvement	4	4
Fever	4	4
Paralysis	4	4
Ambulation Difficulties	4	4
Device Embedded In Tissue or Plaque	4	4
Thrombosis/Thrombus	4	4
Loss of Range of Motion	4	4
Hypoxia	3	3
Paraplegia	3	3