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

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 02/01/2018

Event Type  Injury  

Event Description

It was reported that allegedly the patient's magec rods were damaged.The physician revised the rods without incident.

Manufacturer Narrative

A visual inspection of the returned devices revealed to be partially distracted with score marks on the distraction rods.The rods could be lengthened by hand when pulling on the distraction rod, which confirms the pin failures.Dhr review revealed that this unit was built prior to the release of the new pin.

Event Description

It was reported the after the failure to lengthen on (b)(6) 2018.Radiographs were reviewed back to the first visit at chop and the right threaded rod had been fractured all along.The left was functioning until (b)(6) 2018.Conversion to psf.Patient outcome excellent, and no complications.

• 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: 8017599
• MDR Text Key: 125429619
• Report Number: 3006179046-2018-00101
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• 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: 09/18/2018

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 48