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

Model Number MS1-4590R

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

Device yet to be obtained.

Event Description

It was reported that a patient's magec rod is damaged.The physician revised the magec rod with a new magec rod without incident.

Manufacturer Narrative

A visual inspection of the magec rod (b)(4) revealed to be partially distracted with score marks on the distraction rod.The rod could be lengthened by hand when pulling on the distraction rod, which confirms the pin failure.Dhr review revealed this unit was built prior to the release of the new pin.A visual inspection for lot (a150128-11) confirmed to be broken on the solid section portion of the end cap.A dimple in the rod was observed next to the location of the break indicating the break to be at the location of the fixation screw.

Event Description

The magec rod, 4.5mm 90mm offset reportedly is fractured.No patient injury reported.

• 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: 8031332
• MDR Text Key: 125902533
• Report Number: 3006179046-2018-00103
• Device Sequence Number: 0
• Product Code: PGN
• PMA/PMN Number: K140613
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-4590R
• Device Catalogue Number: PA0517
• Device Lot Number: A150128-11-00-03U
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR