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

Model Number RA002-4545SL

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that after the first distraction the rod was found to be broken via x-ray.The rod has been removed and replaced.No additional information has been provided.

Manufacturer Narrative

Additional data: b5, h6, h10.The device has not been returned to nuvasive for evaluation.This investigation was conducted based on the provided x-ray images.The x-ray images confirmed the rod was broken at the solid section.Without the return of the device, the root cause is unable to be determined.A review of the device history record (dhr) confirmed the device met all required quality inspections and specifications prior to release.

Event Description

No additional information has been provided.

Manufacturer Narrative

Device evaluation: the rod has been returned to nuvasive for evaluation.Upon visual inspection, the device was found in two pieces, the main housing body and a small section of the rod.Initial visual examination revealed no additional damage aside from the broken rod section.In-house x-rays confirmed that there is no internal damage to the device.Functional testing was performed and the device functioned as intended as it was able to be distracted.The force test was unable to be conducted due to the bending of the rod ends to conform to the patient's body shape.Although the exact root cause is unknown, based off of the information provided, it is possible that the break may have resulted from fatigue caused by bending during routine daily activities given that the patient was fully weightbearing while using the device.

Event Description

No additional information has been provided.

• 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: 17777043
• MDR Text Key: 323797205
• Report Number: 3006179046-2023-00340
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K201543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-4545SL
• Device Lot Number: 2031003AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 15 KG