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

Model Number MC2-4570S

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Devices remain implanted.

Event Description

It was reported that allegedly one of the dual magec rods on the left side of the patient is not distracting.Additionally, the cap has come loose on the rod.The physician's course of action is to remove the affected rod.

Manufacturer Narrative

The rod was returned for evaluation and the reported event was confirmed.Functional testing revealed that the rod would not distract.Root cause was due to the end cap disengaging.

Manufacturer Narrative

A review of the device history record (dhr) confirmed the device met all of the required inspections and specifications at the time it was released.Device evaluation: functional testing could not be completed as the device was received in pieces.As a result, the reported distraction issue could not be confirmed.Visual inspection revealed end cap was disengaged from the rod, the retaining ring was missing, and there was a fracture through the pin hole at the distal end of the lead screw.Per the surgeon, the clip ring may have failed prior to rod removal but the clip had been removed from the patient and possibly lost during the decontamination process; however, the surgeon stated the lead screw fracture likely occurred as a result of the use of a rod gripper and hammer during rod removal.Visual inspection also noted the o-ring seal was intact, the radial bearing was clean, and the locking pin was intact and properly seated in the magnet module.A definitive cause of the reported distraction issue cannot be determined; however, based on the evaluation findings, it is possible the distraction issue was a result of the end cap disengagement.End cap disengagement issues were addressed under recall 3006179046-02/20/2020-r (fda # z-1898-2020).It was also reported the surgeon noted moderate metallosis during the rod removal procedure; however, no objective evidence has been provided and therefore, the reported metallosis was unable to be confirmed.

Event Description

Additional information has been received that the surgeon noted moderate metallosis during removal of the 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: geoff gannon ; 101 enterprise suite 100; aliso viejo, CA 92656
• MDR Report Key: 8880912
• MDR Text Key: 162120350
• Report Number: 3006179046-2019-00128
• 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,Followup,Followup
• Report Date: 09/13/2023

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
• Device Model Number: MC2-4570S
• Device Lot Number: 8062307AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 08/14/2023
• Supplement Dates FDA Received: 12/20/2019; 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 18 KG