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

Model Number RA002-5555SL70

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for investigation.Root cause is unable to be determined at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter the rod failed to extend.

• 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 dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr. suite 100; aliso viejo, CA 92656
• MDR Report Key: 10497380
• MDR Text Key: 206356117
• Report Number: 3006179046-2020-00386
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002152
• UDI-Public: 856719002152
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2020

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
• Device Operator: Health Professional
• Device Model Number: RA002-5555SL70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/04/2020
• 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 Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 9 YR