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

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation therefore an analysis was not performed.An inspection of the x-ray image provided confirmed the magec rod has not distracted.No further investigation could be conducted due to no return.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.

Event Description

It was reported that allegedly the patient's magec rod is not distracting.The patient has received multiple surgeries related to other illnesses, and the patient is incredibly ill.Therefore, the physician will not be revising the magec rod.

• 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer Contact: claudia alvarez ; 101 enterprise, suite 100; aliso viejo, CA 92656 ; 9496528012
• MDR Report Key: 8414904
• MDR Text Key: 138814821
• Report Number: 3006179046-2019-00019
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR