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

Model Number MC2-5090S

Device Problems Crack (1135); Fracture (1260); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.

Event Description

Information was received that the magnet on the rod was cracked.

Manufacturer Narrative

Corrected data: d9, e1.Additional data: a2, a3, b5, d8, h5, h6.

Event Description

Additional information was received that the rod stopped distracting and was later found to be fractured at the actuator.

• 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 Key: 9960756
• MDR Text Key: 188716403
• Report Number: 3006179046-2020-00265
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517834041
• UDI-Public: 887517834041
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-5090S
• Device Lot Number: 8071101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR