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
XELITE BIOMED LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Improper Chemical Reaction	260	260
Adverse Event Without Identified Device or Use Problem	245	245
Leak/Splash	187	187
Fluid/Blood Leak	171	171
Chemical Problem	160	160
Migration or Expulsion of Device	155	155
Failure to Eject	125	125
Material Integrity Problem	125	125
Inflation Problem	107	107
Migration	89	89
Coagulation in Device or Device Ingredient	70	70
Break	64	64
Compatibility Problem	30	30
Appropriate Term/Code Not Available	24	24
Fracture	20	22
No Apparent Adverse Event	19	19
Insufficient Information	17	17
Entrapment of Device	16	16
Activation Failure	13	14
Product Quality Problem	12	12
Packaging Problem	12	12
Activation, Positioning or Separation Problem	11	11
Difficult or Delayed Separation	11	15
Separation Failure	10	10
Improper or Incorrect Procedure or Method	7	7
Device-Device Incompatibility	6	6
Mechanical Problem	6	6
Crack	6	6
Difficult to Remove	5	5
Patient Device Interaction Problem	5	5
Device Handling Problem	5	5
Device Damaged Prior to Use	4	4
Clumping in Device or Device Ingredient	4	4
Device Difficult to Setup or Prepare	4	4
Use of Device Problem	4	4
Device Difficult to Maintain	4	4
Detachment of Device or Device Component	3	3
Tear, Rip or Hole in Device Packaging	3	3
Material Separation	3	3
Excess Flow or Over-Infusion	3	3
Deflation Problem	3	3
Expiration Date Error	3	3
Pressure Problem	3	3
Device Ingredient or Reagent Problem	3	3
Mechanics Altered	2	2
Material Rupture	2	2
Material Fragmentation	2	2
Contamination /Decontamination Problem	2	2
Inaccurate Information	2	2
Problem with Sterilization	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	941	948
Insufficient Information	150	151
Extravasation	139	139
No Known Impact Or Consequence To Patient	110	110
No Consequences Or Impact To Patient	104	104
Pain	64	64
Bone Fracture(s)	64	64
No Code Available	52	52
Nerve Damage	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Foreign Body In Patient	37	37
Pulmonary Embolism	28	28
Unspecified Tissue Injury	28	28
Post Operative Wound Infection	26	26
Osteolysis	26	26
Unspecified Infection	26	26
Hematoma	25	25
Failure of Implant	24	24
Non-union Bone Fracture	24	24
Joint Laxity	21	21
Injury	16	16
Embolism/Embolus	15	15
Decreased Sensitivity	13	13
Cerebrospinal Fluid Leakage	12	12
Spinal Cord Injury	10	10
Necrosis	10	10
Cardiac Arrest	10	10
Dyspnea	10	10
Vertebral Fracture	9	9
Perforation of Vessels	9	9
No Patient Involvement	9	9
Death	8	8
Arrhythmia	8	8
Device Embedded In Tissue or Plaque	7	7
Impaired Healing	7	7
Paralysis	7	7
Chest Pain	6	6
Stenosis	6	6
Weakness	6	6
Unspecified Nervous System Problem	6	6
Physical Asymmetry	5	5
Hypersensitivity/Allergic reaction	5	5
Inflammation	5	5
Neck Pain	5	5
Pleural Effusion	4	4
Thrombosis/Thrombus	4	4
Loss of Range of Motion	4	4
Neurological Deficit/Dysfunction	4	4
Pneumonia	4	4
Dysphagia/ Odynophagia	4	4