MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number MS1-4590S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2017

Event Type  Injury  

Event Description

The patient was seen in orthopedic clinic for growth spinal rod lengthening with a magnet.The md made 3-4 attempts to lengthen rods without success.Arrangements were made to remove and replace the malfunctioning rods.Surgery to remove and replace the rods was scheduled for a few months later.The vendor returned the rods to the manufacturer for testing.No report available at this time.

• Brand Name: MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6940106
• MDR Text Key: 88952337
• Report Number: 6940106
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: MS1-4590S
• Device Catalogue Number: PA0516
• Device Lot Number: A141219-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 10 YR
• Patient Weight: 33