MAUDE Adverse Event Report: NUVASIVE, INC. MAGEC; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number MC2-5070S

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

In 2021, the patient had nuvasive magec rods placed as part of the management of infantile scoliosis.He presented for exchange of his growth rods.Following dissection of the spine to access the rods for removal.On removal, the right rod was noted to no longer distracting when a temporary magnet was placed onto the rod.The anchors appeared to be secure and the new rod was placed.The left rod was then exposed and noted that the two ends of the rod were moving independently.Each end of the rod was removed separately.The hooks for the upper end of the rod were loose and needed to be replaced.

• Brand Name: MAGEC
• Type of Device: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 16794809
• MDR Text Key: 313826993
• Report Number: 16794809
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MC2-5070S
• Device Catalogue Number: MC2-5070S
• Device Lot Number: 9090608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4380 DA
• Patient Sex: Male