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

Model Number RA002-5555SL

Device Problem Mechanical Problem (1384)

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

Event Date 11/10/2021

Event Type  malfunction  

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.

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.

Event Description

Additional information was received on january 24, 2022 that there was no metallosis found in relation to this rod.

Event Description

No additional information was provided.

Manufacturer Narrative

During visual inspection, the returned rod was observed to be partially distracted with score marks consistent with expected markings due to incremental distraction.X-ray images of internal components for the rod revealed a broken radial ball bearing.The rod was functionally tested and could not distract and retract with the electronic remote controller (erc) and the manual distractor.The rod was disassembled by sectioning the housing tube and the broken radial ball bearing was confirmed.The broken radial ball bearing led the unit to fail to distract.The cause of the broken ball bearing could possibly be from excess stress applied to the rod due to the patient's daily activities or unique anatomical structure.The iqc inspection data for the lot of radial ball bearing was reviewed, and the parts met design specifications per the engineering drawings.As part of the investigation, the work order was reviewed and confirmed the device passed all inspections per the acceptance tests.Review of the device history records indicated that the unit met all quality specifications prior to shipment.

• 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: 13297001
• MDR Text Key: 286527777
• Report Number: 3006179046-2022-00112
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• 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: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SL
• Device Lot Number: A18012304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• 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 Outcome(s): Hospitalization
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 35 KG