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

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in the patient.

Event Description

It was reported that allegedly the patient's magec rods are not distracting.The rods will be revised.

Manufacturer Narrative

A visual inspection of the returned devices were observed to be partially distracted.The rod were functionally tested and could not be distracted or retracted using the manual distractor or erc.The rods were cut open and debris build up was found, which may caused the reduced functionality of the rods.A device history record review revealed that the magec rods met all the required quality inspections and was released within specifications.

Event Description

My 11 year old son has sma and received magec rods in (b)(6) 2015 at (b)(6).The rods are not lengthening any longer, for an unknown reason.They are not maxed out in length yet and my son¿s spine has not fused yet.We are planning to exchange out the rods.

• 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: 8011800
• MDR Text Key: 126383583
• Report Number: 3006179046-2018-00100
• 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: 09/26/2018

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?: Yes
• 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: 10/28/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR