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
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	315	315
Coagulation in Device or Device Ingredient	254	254
Adverse Event Without Identified Device or Use Problem	232	232
Leak/Splash	225	225
Fluid/Blood Leak	216	216
Inflation Problem	182	182
Material Integrity Problem	172	172
Migration or Expulsion of Device	161	161
Failure to Eject	157	157
Chemical Problem	123	123
Break	75	75
Compatibility Problem	72	72
Migration	65	65
Product Quality Problem	31	31
Fracture	27	34
Activation Failure	22	24
No Apparent Adverse Event	21	21
Activation, Positioning or Separation Problem	20	20
Entrapment of Device	18	18
Insufficient Information	17	17
Separation Failure	16	17
Appropriate Term/Code Not Available	16	16
Difficult or Delayed Separation	15	19
Device-Device Incompatibility	13	13
Packaging Problem	12	12
Patient Device Interaction Problem	10	10
Device Damaged Prior to Use	8	8
Use of Device Problem	8	8
Mechanical Problem	7	7
Improper or Incorrect Procedure or Method	6	6
Crack	5	5
Clumping in Device or Device Ingredient	5	5
Pressure Problem	5	5
Device Ingredient or Reagent Problem	5	5
Expiration Date Error	4	4
Device Handling Problem	4	4
Detachment of Device or Device Component	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Nonstandard Device	3	3
Tear, Rip or Hole in Device Packaging	3	3
Defective Device	2	2
Contamination /Decontamination Problem	2	2
Off-Label Use	2	2
Material Fragmentation	2	2
Inaccurate Information	2	2
Excess Flow or Over-Infusion	2	2
Mechanics Altered	2	2
Material Separation	2	2
Mechanical Jam	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1446	1456
Insufficient Information	183	185
Extravasation	129	129
No Consequences Or Impact To Patient	59	59
Bone Fracture(s)	59	59
Pain	55	55
Foreign Body In Patient	42	43
Nerve Damage	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Pulmonary Embolism	36	36
No Code Available	35	35
Unspecified Infection	34	34
Post Operative Wound Infection	29	29
Unspecified Tissue Injury	28	28
No Known Impact Or Consequence To Patient	27	27
Osteolysis	26	26
Failure of Implant	24	24
Hematoma	23	23
Joint Laxity	21	21
Non-union Bone Fracture	21	21
Embolism/Embolus	16	16
Injury	15	15
Cardiac Arrest	14	14
Decreased Sensitivity	13	13
Cerebrospinal Fluid Leakage	11	11
Necrosis	10	10
Vertebral Fracture	10	10
Spinal Cord Injury	9	9
Perforation of Vessels	9	9
Dyspnea	9	9
Unspecified Nervous System Problem	8	8
Impaired Healing	7	7
Stenosis	6	6
Low Blood Pressure/ Hypotension	6	6
Chest Pain	6	6
Hemorrhage/Bleeding	6	6
Physical Asymmetry	5	5
Neck Pain	5	5
Hypersensitivity/Allergic reaction	5	5
Thrombosis/Thrombus	4	4
No Patient Involvement	4	4
Paralysis	4	4
Loss of Range of Motion	4	4
Fever	4	4
Dysphagia/ Odynophagia	4	4
Inflammation	4	4
Swelling/ Edema	4	4
Death	4	4
Ambulation Difficulties	4	4
Device Embedded In Tissue or Plaque	4	4