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

Model Number UNKNOWN

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation as it remains in-situ.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that the rod was not distracting.No patient harm was reported.

Manufacturer Narrative

Additional data.

Event Description

Additional information was received.

• 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
• MDR Report Key: 12159413
• MDR Text Key: 261313956
• Report Number: 3006179046-2021-00403
• Device Sequence Number: 1
• Product Code: PGN
• 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: 07/13/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR