MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number RA002-4545SL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Metal Related Pathology (4530)

Event Date 07/11/2023

Event Type  Injury  

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 during removal it was noted that metallosis had developed.No additional information has been provided.

Event Description

Additional information has been provided.

Manufacturer Narrative

A review of the device history record (dhr) confirmed the device met all required quality inspections and specifications prior to release.The rod was not returned for evaluation.This investigation was conducted using the provided photo images.The photos reflected some black debris of an unknown origin on the device.Without the return of the device, no further inspection can be conducted and the root cause cannot be determined.Although a root cause is unable to be determined, objective evidence has determined that there is no direct evidence of any serious or systematic effects due to metallosis and the effects is limited to local tissue discoloration.

Event Description

No additional information has been provided.

• Brand Name: MAGEC GENERATION 1.5 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: 17398317
• MDR Text Key: 319841019
• Report Number: 3006179046-2023-00314
• 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,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RA002-4545SL
• Device Lot Number: A171115-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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): Other
• Patient Age: 9 YR
• Patient Sex: Female