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, INC. 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, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION, Back to Search Results
Model Number RA002-4545SL
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
It was alleged that the patient's magec rod would not distract.The physician revised the rod with new magec rod without incident.
 
Manufacturer Narrative
An evaluation was performed on the returned nail that did not lengthen post implantation.An inspection of the rod revealed to be partially distracted with score marks on the distract rod.The rod could be lengthened by hand when pulling on the distraction rod, which confirms the pin failure.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.
 
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, INC.
101 enterprise, suite 100
aliso viejo CA 92656
MDR Report Key7835510
MDR Text Key118867436
Report Number3006179046-2018-00050
Device Sequence Number1
Product Code PGN
Combination Product (y/n)N
PMA/PMN Number
K140613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/27/2018
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? No
Device Operator Health Professional
Device Model NumberRA002-4545SL
Device Catalogue NumberPA0237
Device Lot NumberA150128-10-00-01C
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/27/2018
Initial Date FDA Received08/30/2018
Supplement Dates Manufacturer Received07/27/2018
Supplement Dates FDA Received11/02/2018
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-