MAUDE MDR 9908788

MDR report key: 9908788
Report number: 3006179046-2020-00162
Event key: 0
Event type: 3
Date of event: 2020-01-22
Date received: 2020-03-31
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MS. TIARA RAE
Address: 101 ENTERPRISE SUITE 100 ALISO VIEJO CA 92656 US
Phone: 619-619-6197
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	GROWING ROD SYSTEM-MAGNETIC ACTUATION	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	RA002-4545SLR						R	*

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-03-31	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00887517834010	MAGEC	Nuvasive, Inc.	PGN	2017-09-09
00887517834027	MAGEC	Nuvasive, Inc.	PGN	2017-09-09
00887517834034	MAGEC	Nuvasive, Inc.	PGN	2017-09-09
00887517834041	MAGEC	Nuvasive, Inc.	PGN	2017-09-09
00856719002114	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00856719002138	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00856719002145	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00856719002152	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00856719002169	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00856719002183	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00856719002190	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00856719002244	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022600	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022617	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022624	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022631	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022648	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022655	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022662	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022679	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022686	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022693	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022709	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258022716	MAGEC® Spinal Bracing and Distraction System	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2016-01-15
00812258026882	MAGEC® Manual Distractor	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2015-12-23
00812258026899	MAGEC Wand	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2015-12-23
00856719002107	External Remote Controller	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2015-10-15
00812258022242	MAGEC® Manual Distractor	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2015-10-15
00812258022259	MAGEC Wand	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2015-10-15
00812258022723	MAGEC® Manual Distractor	NUVASIVE SPECIALIZED ORTHOPEDICS, INC.	PGN	2015-10-15

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K233593	PGN	MAGEC Spinal Bracing and Distraction System	Nuvasive Specialized Orthopedics, Incorporated	2024-02-06
510(k)	K201543	PGN	MAGEC® System	Nuvasive Specialized Orthopedics, Inc.	2020-07-30
510(k)	K171791	PGN	MAGEC® System	Nuvasive Specialized Orthopedics, Incorporated	2017-08-31
510(k)	K160352	PGN	MAGEC® Spinal Bracing and Distraction System	Nuvasive Specialized Orthopedics, Inc.	2016-10-21
510(k)	K161751	PGN	MAGEC® Spinal Bracing and Distraction System	Nuvasive Specialized Orthopedics, Inc.	2016-09-02

MAUDE MDR 9908788

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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Related PMN/PMA Records By Product Code#