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 Fracture (1260)

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.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 a rod fracture.It was reported the rod had achieved intended distraction goals and had fractured only a short time prior to the revision surgery.There was no report of patient fall, accident, or other traumatic event.No further adverse patient impact and no patient harm was reported.No additional information is available.

Event Description

No additional information has been provided.

Manufacturer Narrative

Additional data: b5, h6, h10.Device evaluation: the magec rod was not returned to nuvasive for an in-person evaluation.This investigation has been conducted based on the provided x-ray images of the patient¿s body.The x-ray image reveals a broken rod which confirmed the rod has been broken at a solid section on the distal end of the actuator.The exact cause of the reported failure could not be determined without the return of the device or additional information.

• 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: 15846272
• MDR Text Key: 304881716
• Report Number: 3006179046-2022-00272
• 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: K201543
• 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: 12/06/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 10 YR
• Patient Sex: Male