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
Lot Number 100224-005-005
Device Problem Mechanical Jam (2983)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by (b)(6).If additional relevant information is obtained, then a follow-up mdr will be submitted.
 
Event Description
It was reported that a revision procedure was performed for an unknown reason.During a review of investigation findings from lirc it was identified that the rod had evidence galling and corrosion.Additionally it was reported that the rod was unable to be retracted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Type of Device
GROWING ROD SYSTEM-MAGNETIC ACTUATION
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
101 enterprise #100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
101 enterprise #100
aliso viejo CA 92656
Manufacturer Contact
geoff gannon
101 enterprise #100
aliso viejo, CA 92656
8583448112
MDR Report Key12136020
MDR Text Key260527684
Report Number3006179046-2021-00376
Device Sequence Number1
Product Code PGN
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K171791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number100224-005-005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-