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

Model Number UNKNOWN

Device Problem Naturally Worn (2988)

Patient Problems Infiltration into Tissue (1931); Inflammation (1932)

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 relevant additional information is been provided, a supplemental report will be submitted.Journal citation: t.Zhang, et al.Systematic investigation of metallosis associated with magnetically controlled growing rod implantation for early-onset scoliosis.Bone joint journal 2020;102-b(10):1375¿1383.

Event Description

Information received via journal article review: biopsies of paraspinal muscles from ten patients with early onset scoliosis undergoing unidentified magnetically controlled growth rod exchange were studied.Spectral and histological analyses were made and revealed titanium (ti), vanadium (v), and neodymium (nd) in the biopsies along with mild-to-moderate chronic inflammation.Chronic inflammation was revealed by the histological studies with fibrosis and macrophage infiltration.Black particles were present within the macrophages in the fibrotic tissues.The journal article concluded that ti and v were generated due to wear/metal on metal contact and the nd possibly released during distraction sessions.No additional information is available.

• 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, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 11785440
• MDR Text Key: 249461031
• Report Number: 3006179046-2021-00268
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2021

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: 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
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/06/2021
• 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
• Patient Outcome(s): Other