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

Model Number UNKNOWN

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

Patient Problems Inflammation (1932); Metal Related Pathology (4530)

Event Date 05/14/2022

Event Type  Injury  

Event Description

It was reported that upon planned removal of the rod after lengthening goals had been achieved, it was noted there was "metallosis" in the tissue around the magnet area of the rod.The tissue around the companion rod did not exhibit this issue.There was no reported patient injury as a result of this issue.No additional information is available.

Manufacturer Narrative

The device has not been returned for evaluation and no product or lot information is available.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

No additional information has been provided.

Manufacturer Narrative

The unit has not been returned to nuvasive for in person investigation.No device lot number was provided nor was it able to be obtained.This investigation was performed based on provided intraoperative photographs and a pathology report.During evaluation of the provided intraoperative photographs, presences of possible black discolored tissue along the rod were observed which confirmed the report of tissue discoloration/metallosis.Additionally, the provided pathology report confirms metallosis of the muscle.The nuvasive medical director was consulted to help clarify the complaint description and the provided pathology report.Clarification has revealed that it is not likely that there is a connection between metallic wear debris (or metal ions) causing an elevated ana titer (which is usually associated with autoimmune diseases).However, metal debris is associated with chronic inflammation which was found in the tissue pathology report.Additionally, the titanium metallosis is unlikely to be associated directly with an abnormal ekg and pericardial effusion.The exact root cause of the confirmed 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: 14644919
• MDR Text Key: 293646811
• Report Number: 3006179046-2022-00203
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNKNOWN MAGEC ROD.
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Sex: Female