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

Model Number RA002-5555SLR

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Information was received that a rod was explanted and replaced as it failed to distract.Additionally, it was reported that metallosis was found on the rod.No further patient impact 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, the device was visually inspected.It was observed to be partially distracted without any evidence of metallosis.X-ray images of the internal components showed no obvious damaged and confirmed the visual observation of the device being partially distracted.The device was functionally testing and was able to distract and retract with the electronic remote controller (erc), manual and fast distractor.The device was able to achieve its minimum and maximum lengths during testing.The reported failure mode was unable to be confirmed as the rod was fully functional and met acceptance test specifications.No objective evidence was found for metallosis.Additionally, lab results have not been made available to confirm metallosis.The device history records were reviewed, and found the device was manufactured in accordance with the specified requirements and met all the required quality inspections.There were no discrepancies or non-conformances related to the reported event.

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 ; 8583448112
• MDR Report Key: 13297036
• MDR Text Key: 284448331
• Report Number: 3006179046-2022-00113
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002114
• UDI-Public: 856719002114
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SLR
• Device Lot Number: A170919-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• 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): Hospitalization
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 35 KG