MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number RA002-4545SLR

Device Problems Structural Problem (2506); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

An investigation report from an implant retrieval center was received and reported that during examination of the rod, the retrieval center found the rod exerted 35.3lbf during force testing which did not meet the specification.Additionally, upon initial disassembly the magnet, radial bearing, and extending bar were found to be seized together and the components were unable to be separated, therefore, the drive pin was unable to be examined.It was additionally reported that the o-ring seal was found to have been snapped in three pieces.No additional information is available.

Manufacturer Narrative

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.

Manufacturer Narrative

Corrected h6- device code.

Event Description

No additional information provided.

• Brand Name: MAGEC GENERATION 1 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: 16353731
• MDR Text Key: 309585010
• Report Number: 3006179046-2023-00113
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: A140313-18
• Was Device Available for Evaluation?: No
• 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: 03/13/2014
• 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 Sex: Prefer Not To Disclose