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

Model Number MC2-6090R

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation as it remains in-situ.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 x-ray showed the endcap of the rod seems to be popped up (gap between actuator and end cap).It is unknown if a revision procedure is planned at this time.No patient injury has been reported.

Event Description

A revision procedure was performed on an unknown date.

Manufacturer Narrative

Device records review: review of the device history records for the rod confirmed that it met all of the required quality inspections prior to release.Device evaluation: visual inspection of the returned product confirmed the threaded cap was unthreaded from the housing tube.The returned rod was observed to be partially distracted.X-ray imaging inspection was also performed and threaded cap disengagement was noted.This issue is related to field safety notice z-1898-2020.

• 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: 11033846
• MDR Text Key: 227049090
• Report Number: 3006179046-2020-00504
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022716
• UDI-Public: 812258022716
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-6090R
• Device Lot Number: 8122106AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 13 YR
• Patient Weight: 30