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

Model Number RA002-5555SLR70

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Information was received that a revision procedure was performed for the removal the magec rod and conversion to a definitive fusion.As per the reporter, there were a lot of black stains in the tissue where the rods had been lengthening.There was no infection or necrosis.No additional information has been provided at this time.Report 2 of 2.

Manufacturer Narrative

The device has not been returned for evaluation.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.

Event Description

No additional information has been provided.

Manufacturer Narrative

The unit has not been returned to the manufacturer for direct investigation.This investigation was performed based on provided intraoperative photographs.During evaluation of the provided intraoperative photographs, presence of possible black discolored tissue was observed along the location where the rod was placed which confirmed the reported tissue discoloration.The unit¿s work order was reviewed and confirmed that the device passed all quality inspections per the acceptance tests prior to shipment.The exact cause of the reported failure mode could not be determined due to the limited clinical information as well as no device return.

• Brand Name: MAGEC 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: 15106019
• MDR Text Key: 296613749
• Report Number: 3006179046-2022-00232
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002169
• UDI-Public: 856719002169
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K161751
• 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: 08/19/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: RA002-5555SLR70
• Device Lot Number: A161006-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• 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): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 50 KG