MAUDE Adverse Event Report: NUVASIVE MAGEC SPINAL RODS; MAGNETIC SPINAL RODS

Lot Number 21

Device Problem Metal Shedding Debris (1804)

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

Event Date 04/06/2018

Event Type  Injury  

Event Description

Because of a concern with titanium wear debris with growing rod constructs including the magec rod, a serum titanium was obtained of a patient with 2 magec rods implanted.The serum titanium was elevated at 5 ng/ml.

• Brand Name: MAGEC SPINAL RODS
• Type of Device: MAGNETIC SPINAL RODS
• Manufacturer (Section D): NUVASIVE; san diego CA 92121
• MDR Report Key: 7457607
• MDR Text Key: 106634222
• Report Number: MW5076682
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 28