MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number MC2-6090S

Device Problems Break (1069); Corroded (1131); Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

An investigation report from an implant retrieval center was received and reported that the rod would not extend and force testing was unable to be completed.Additionally, it was noted during surface damage grading that there was corrosion on the rod.It was reported that the rod was removed due to a broken rod; there was no adverse patient or user impact associated with this report.No additional information is available.

Manufacturer Narrative

The device has not been returned for evaluation.The evaluation was performed by the london implant retrieval center (lirc).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.Report 1 of 2.

• Brand Name: MAGEC GENERATION 2B 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: 17148877
• MDR Text Key: 317692274
• Report Number: 3006179046-2023-00291
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022709
• UDI-Public: 812258022709
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-6090S
• Device Lot Number: A170123-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2017
• 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: 11 YR
• Patient Sex: Male