MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS MAGEC 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 08/30/2021

Event Type  malfunction  

Event Description

Information was received that during a routine x-ray the rod was found to be broken.No patient adverse event was reported.

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.

Manufacturer Narrative

Upon return, visual inspection of the returned product confirmed the rod was broken at a solid section at the distal end of the actuator, so the reported failure mode was confirmed.Also, the patient's x-ray images confirmed the reported failure.The type of breakage observed can result from excess stress that was applied as a result of the patient's daily activities and unique anatomical structure.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The iqc inspection data for the lot of end cap was reviewed and confirmed the part met design specifications per the engineering drawings.Because the rod met manufacturing specifications assembly, the breakage did not relate to any manufacturing process or material issues.

Event Description

No additional information was provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656
• MDR Report Key: 13012022
• MDR Text Key: 282403374
• Report Number: 3006179046-2021-00516
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002183
• UDI-Public: 856719002183
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-4545SL
• Device Lot Number: 8100122AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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: 8 YR