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

Model Number RA002-4545SLR

Device Problems Break (1069); Mechanical Problem (1384); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Failure of Implant (1924)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation, nor were pictures provided to confirm alleged event.Root cause is unable to be determined at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2020 for definitive fusion as the rods hadn't distracted much over the last 12 months.

Manufacturer Narrative

Corrected data: g4.Additional data: b5, b6, g2, h4, h6, h10.No product has been returned for evaluation.Evaluation was performed by newcastle engineering lab.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

The device was sent to newcastle university engineering lab for evaluation who reported that the rod did not exert any force during force testing.During disassembly the magnet was found to be broken.Unfortunately, no further disassembly was possible as the rest of the rod was seized together.Therefore, the drive pin and the rest of the internal components were unable to be examined.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 10668073
• MDR Text Key: 211539199
• Report Number: 3006179046-2020-00410
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-4545SLR
• Device Lot Number: A170213-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• 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 Outcome(s): Required Intervention; Other
• Patient Age: 11 YR
• Patient Sex: Female