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 Problem Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that the rod is possibly jammed.No additional information has been provided.

Event Description

No additional information has been provided.

Manufacturer Narrative

Device evaluation: visual inspection of the returned rod showed no signs of physical damage to the distraction rod or housing tube.In house x-ray revealed a broken magnet assembly.Functional testing was performed and confirmed the device was not distracting.The reported failure has therefore been confirmed.The exact cause of the failure is unable to be definitively determined.

Manufacturer Narrative

Correction: b5, h6 (health effect - impact code) additional data: h6, h10.Additional device evaluation details: the returned rod was visually inspected and typical scoring was observed on the distraction rod, which is consistent with incremental distraction.Residual bodily fluids were seen between the distraction rod and the housing tube.In-house device x-rays were taken, which showed a broken magnet assembly and a dislocated inner raceway of the bearing.Functional testing was performed, and the rod was unable to be distracted, confirming the reported rod jam.The rod was then sectioned to inspect the internal components and the ball bearing was found to be fractured.Additionally, based on corrosion observed on the components, it was determined bodily fluid ingress into the housing tube likely occurred.Further sectioning confirmed a torn o-ring, possibly a result of patient activity/weight-bearing, which may have allowed the fluid ingress.A definitive root cause is unable to be determined but based on rod evaluation findings, it is possible bodily fluid ingress into the housing led to the material degradation and subsequent fracture of the bearing, which resulted in the rod jamming and possibly the magnet fracture.It should also be noted the device was implanted for approximately 33 months; per the ifu, the device should be removed after an implantation time of no more than two years.Therefore, implantation duration may have been a contributing factor.Should any additional, relevant information become available, a supplemental report will be submitted.

Event Description

Information was received that the rod is possibly jammed.The patient was reportedly full weight bearing.The device was removed for final fusion.There was no reported patient harm.No additional information is available.

• 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: 17492158
• MDR Text Key: 321177762
• Report Number: 3006179046-2023-00320
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• 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,Followup
• Report Date: 11/16/2023

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: 8051606
• 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: 07/19/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 11/16/2023
• Supplement Dates FDA Received: 10/11/2023; 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 46 KG