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

Model Number RA002-5555SL

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.X-rays confirmed the alleged event.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, x ray images revealed bilateral pin breaks.There was no patient injury.

• 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 ; 6197314188
• MDR Report Key: 11033821
• MDR Text Key: 223437293
• Report Number: 3006179046-2020-00502
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2020

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: RA002-5555SL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/17/2020
• 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: 12 YR