TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BIOPSYBELL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BONWRX LTD
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO. LTD.
	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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	239	239
Improper Chemical Reaction	227	227
Leak/Splash	179	179
Fluid/Blood Leak	158	158
Chemical Problem	153	153
Migration or Expulsion of Device	152	152
Material Integrity Problem	120	120
Failure to Eject	103	103
Inflation Problem	95	95
Migration	88	88
Break	59	59
Coagulation in Device or Device Ingredient	49	49
Compatibility Problem	24	24
Appropriate Term/Code Not Available	23	23
Fracture	19	21
No Apparent Adverse Event	18	18
Entrapment of Device	15	15
Insufficient Information	12	12
Packaging Problem	12	12
Activation Failure	12	13
Activation, Positioning or Separation Problem	10	10
Difficult or Delayed Separation	10	12
Separation Failure	9	9
Product Quality Problem	8	8
Improper or Incorrect Procedure or Method	7	7
Device-Device Incompatibility	6	6
Mechanical Problem	6	6
Patient Device Interaction Problem	5	5
Difficult to Remove	5	5
Crack	5	5
Device Handling Problem	5	5
Clumping in Device or Device Ingredient	4	4
Use of Device Problem	4	4
Device Difficult to Maintain	4	4
Device Difficult to Setup or Prepare	4	4
Deflation Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Detachment of Device or Device Component	3	3
Excess Flow or Over-Infusion	3	3
Expiration Date Error	3	3
Device Damaged Prior to Use	3	3
Pressure Problem	3	3
Material Separation	2	2
Inaccurate Information	2	2
Material Rupture	2	2
Mechanics Altered	2	2
Backflow	1	1
Material Discolored	1	1
Device Dislodged or Dislocated	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	833	838
Extravasation	136	136
Insufficient Information	130	131
No Known Impact Or Consequence To Patient	110	110
No Consequences Or Impact To Patient	104	104
Pain	61	61
Bone Fracture(s)	60	60
No Code Available	52	52
Nerve Damage	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Foreign Body In Patient	35	35
Unspecified Tissue Injury	27	27
Pulmonary Embolism	26	26
Unspecified Infection	24	24
Osteolysis	24	24
Failure of Implant	24	24
Post Operative Wound Infection	23	23
Non-union Bone Fracture	23	23
Hematoma	22	22
Joint Laxity	18	18
Injury	16	16
Embolism/Embolus	15	15
Decreased Sensitivity	10	10
Spinal Cord Injury	10	10
Cardiac Arrest	10	10
Necrosis	10	10
Vertebral Fracture	9	9
No Patient Involvement	9	9
Cerebrospinal Fluid Leakage	9	9
Dyspnea	9	9
Perforation of Vessels	9	9
Death	8	8
Paralysis	7	7
Arrhythmia	7	7
Stenosis	6	6
Weakness	6	6
Device Embedded In Tissue or Plaque	6	6
Impaired Healing	6	6
Chest Pain	6	6
Physical Asymmetry	5	5
Hypersensitivity/Allergic reaction	5	5
Neck Pain	5	5
Pneumonia	4	4
Dysphagia/ Odynophagia	4	4
Swelling/ Edema	4	4
Neurological Deficit/Dysfunction	4	4
Unspecified Nervous System Problem	4	4
Loss of Range of Motion	4	4
Ambulation Difficulties	4	4
Thrombosis/Thrombus	4	4