Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION Back to Search Results
Model Number MS1-5590R
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/15/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by (b)(6).Device returned to (b)(6).
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2019 for an unknown reason.As per the reporter during servicing it was identified that the o-ring was damaged, the lead screw had seized and the drive pin was broken.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Common Device Name
GROWING ROD SYSTEM-MAGNETIC ACTUATION
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key9950977
Report Number3006179046-2020-00182
Device Sequence Number16982859
Product Code PGN
UDI-Device Identifier00812258026318
UDI-Public812258026318
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K171791
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberMS1-5590R
Device Lot NumberA141122-10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/11/2019
Initial Report FDA Received Date04/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age7 YR
-
-