TPLC - Total Product Life Cycle

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Device	shunt, central nervous system and components
Product Code	JXG
Regulation Number	882.5550
Device Class	2

Premarket Reviews
Manufacturer	Decision
AESCULAP INC.
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	7
ALCYONE LIFESCIENCES. INC.
	SUBSTANTIALLY EQUIVALENT	1
ANUNCIA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
AQUEDUCT CRITICAL CARE, INC
	SUBSTANTIALLY EQUIVALENT	1
AQUEDUCT CRITICAL CARE, INC.
	SUBSTANTIALLY EQUIVALENT	3
ARKIS BIOSCIENCES INC.
	SUBSTANTIALLY EQUIVALENT	1
BORVO MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
BTG INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	9
INTEGRA LIFESCIENCES CORP.
	SUBSTANTIALLY EQUIVALENT	3
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
IRRAS INC.
	SUBSTANTIALLY EQUIVALENT	1
IRRAS USA
	SUBSTANTIALLY EQUIVALENT	1
IRRAS USA INC.
	SUBSTANTIALLY EQUIVALENT	2
IRRAS USA, LTD.
	SUBSTANTIALLY EQUIVALENT	1
JMED(SHENZHEN) TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC NEUROSURGERY
	SUBSTANTIALLY EQUIVALENT	6
MOLLER MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
NEURODX DEVELOPMENT LLC
	SUBSTANTIALLY EQUIVALENT	1
SOPHYSA
	SUBSTANTIALLY EQUIVALENT	1
SOPHYSA SA
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Infusion or Flow Problem	2426	2426
Mechanical Problem	1164	1164
Adverse Event Without Identified Device or Use Problem	1049	1049
Break	1012	1012
Insufficient Information	977	977
Obstruction of Flow	872	872
Appropriate Term/Code Not Available	826	826
Occlusion Within Device	516	516
Leak/Splash	514	514
Device Operates Differently Than Expected	496	496
Fluid/Blood Leak	459	459
Programming Issue	384	384
Pressure Problem	298	298
Fracture	280	280
No Flow	278	278
Disconnection	267	267
Complete Blockage	231	231
Mechanics Altered	197	197
Partial Blockage	184	184
Crack	177	177
Device Dislodged or Dislocated	167	167
Device Difficult to Program or Calibrate	150	150
Excess Flow or Over-Infusion	138	138
Insufficient Flow or Under Infusion	136	136
Mechanical Jam	134	134
Improper Flow or Infusion	121	121
Use of Device Problem	113	113
Output Problem	107	107
Device Operational Issue	97	97
Inaccurate Flow Rate	87	87
Migration	81	81
Migration or Expulsion of Device	81	81
Material Separation	73	73
Detachment of Device or Device Component	65	65
Electrical /Electronic Property Problem	65	65
Material Integrity Problem	60	60
Defective Device	56	56
Detachment Of Device Component	51	51
Material Split, Cut or Torn	51	51
Device Issue	42	42
Material Fragmentation	38	38
Defective Component	34	34
Loose or Intermittent Connection	33	33
Material Puncture/Hole	31	31
Incorrect, Inadequate or Imprecise Result or Readings	31	31
Blocked Connection	29	29
Separation Problem	29	29
Positioning Problem	28	28
Cut In Material	27	27
Connection Problem	25	25

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hydrocephalus	2438	2438
No Known Impact Or Consequence To Patient	2137	2137
No Information	1528	1528
No Clinical Signs, Symptoms or Conditions	1092	1092
Headache	688	689
Failure of Implant	666	666
Unspecified Infection	659	659
Therapeutic Response, Decreased	659	659
No Code Available	567	567
Injury	540	540
Insufficient Information	499	499
No Consequences Or Impact To Patient	336	336
Cerebrospinal Fluid Leakage	305	305
Vomiting	245	245
Cerebral Ventriculomeglia	178	178
Patient Problem/Medical Problem	178	178
Therapeutic Effects, Unexpected	163	163
Ambulation Difficulties	146	146
Hematoma	134	134
Unspecified Tissue Injury	129	129
Fever	116	116
Pain	115	116
Dizziness	113	113
Nausea	111	112
Bacterial Infection	89	89
Death	88	88
Device Embedded In Tissue or Plaque	83	83
Coma	83	83
Cognitive Changes	81	81
Complaint, Ill-Defined	79	79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	77	77
Neurological Deficit/Dysfunction	69	69
Confusion/ Disorientation	68	68
Foreign Body In Patient	64	64
Intracranial Hemorrhage	64	64
Visual Impairment	59	59
Hemorrhage/Bleeding	57	57
Swelling	52	53
Meningitis	51	51
Fatigue	50	51
Loss of consciousness	50	50
Lethargy	49	49
Convulsion/Seizure	47	47
Seizures	42	42
Discomfort	38	39
No Patient Involvement	36	36
Swelling/ Edema	30	30
Hemorrhage, Subdural	29	29
Abdominal Pain	28	28
Inflammation	28	28

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra Neuro Sciences	II	Sep-08-2009
2	Aesculap Implant Systems LLC	II	Mar-01-2018
3	Aesculap, Inc.	II	Jan-26-2015
4	Aesculap, Inc.	III	Dec-16-2014
5	Aesculap, Inc.	II	Dec-03-2014
6	Aesculap, Inc.	II	Jun-02-2014
7	Aesculap, Inc.	II	Feb-19-2014
8	Aesculap, Inc.	II	Feb-12-2013
9	Codman & Shurtleff, Inc.	II	Oct-20-2014
10	Codman & Shurtleff, Inc.	II	Aug-12-2014
11	Codman & Shurtleff, Inc.	II	Apr-17-2014
12	Codman & Shurtleff, Inc.	II	Jan-29-2014
13	Integra LifeSciences Corp	II	Jul-10-2012
14	Integra LifeSciences Corp.	II	Jun-12-2024
15	Integra LifeSciences Corp.	II	Dec-23-2020
16	Integra LifeSciences Corp.	I	May-20-2019
17	Integra LifeSciences Corp.	II	Sep-30-2016
18	Integra LifeSciences Corp.	II	Jan-03-2014
19	Integra LifeSciences Corp. d.b.a. Integra Pain Management	II	Dec-20-2013
20	Integra Neurosciences PR, Inc.	II	Feb-16-2012
21	Medtronic Neurosurgery	II	Aug-17-2023
22	Medtronic Neurosurgery	II	Feb-12-2021
23	Medtronic Neurosurgery	II	Jan-15-2021
24	Medtronic Neurosurgery	II	Dec-28-2020
25	Medtronic Neurosurgery	I	Apr-07-2017
26	Medtronic Neurosurgery	II	Feb-02-2017
27	Medtronic Neurosurgery	I	Jun-27-2014
28	Medtronic Neurosurgery	II	Nov-26-2013
29	Medtronic Neurosurgery	I	Mar-27-2009
30	Natus Manufacturing Limited	II	Feb-22-2021
31	Natus Medical Incorporated	II	Jan-04-2024