MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number MS1-4590S

Device Problems Mechanical Problem (1384); Failure to Advance (2524); Material Deformation (2976)

Patient Problems Foreign Body Reaction (1868); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

The device has been returned and is pending evaluation.The root cause cannot be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that a revision procedure was performed due to the rod malfunctioning and failing to continue extending.Upon removal, the extender was found to be pistoning and there were extremely deep cuts from the pistoning compared to expected normal wear and tear.The rod was additionally reported to have released a large amount of black discharge leading to a large amount of black tissue.

Event Description

No additional information has been provided.

Manufacturer Narrative

Additional data: b5, h3, h6, h10 device evaluation: an initial visual inspection of the returned device revealed some scoring on the distraction rod, but no deep cuts were observed.The housing tube appeared to have some rust coloring.A review of the provided photo images visually confirmed the blackening of the tissue.There was no ¿pistoning¿ observed prior to functional testing.A functional test was attempted and confirmed the reported failure to distract.During testing the device did not move with either the fast distractor, distraction test fixture or external remote controller (erc).The in-house device x-ray revealed that the bearing broke in two pieces.The rod was sectioned on the lathe and the internal components were inspected.Titanium (ti) debris was discovered on multiple components.The bearing was also visually confirmed to be broken with titanium debris covering the magnet.It is likely that the bearing was bound up by the titanium debris.This debris increased the friction inside of the bearing and some axial loading that likely generated the debris contributed to the bearing breaking.The axial loading was likely related to patient-related factors.Device record review: a review of the device history record (dhr) indicates the device was manufactured by the specified requirement at the time and met all of the required inspections before shipment.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 17782957
• MDR Text Key: 323858591
• Report Number: 3006179046-2023-00341
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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 Operator: Health Professional
• Device Model Number: MS1-4590S
• Device Lot Number: 0030605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• 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): Other
• Patient Sex: Prefer Not To Disclose