MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC MAGEC RODS; SPINAL RODS

Lot Number A160620-03 & A150513-07-00-3U

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2016

Event Type  malfunction  

Event Description

Patient has early onset scoliosis and abnormal spine cord.The patient underwent a posterior spinal instrumentation implant approximately three years ago.The implants were stryker screws but ellipse 5.5 implants and ellipse technologies magec 9 cm x 5.5 mm diameter titanium implants, ellipse 5.5mm standard rod with 90mm actuator's lot# a160620-03, ellipse 5.5mm offset rod with 90mm actuator's lot# a150513-07-00-03u and bone grafting posterior arthrodesis t2, t3, t4 and also l1 and l2 with 30 cc of allograft.After two adjustments of the rods, the patient had the rods removed due to the failure of the rods lengthening transcutaneously.The same provider indicated that the hospital is seeing a possible trend with these rods.This patient underwent removal of the rods last month and had replacement with solera 5.5 fixed screws and 5.5 titanium growing rods with 90mm solera connector.No complications and patient was discharged from the hospital without concerns.

• Brand Name: MAGEC RODS
• Type of Device: SPINAL RODS
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC; 101 enterprise ste 100; aliso viejo CA 92656
• MDR Report Key: 9166091
• MDR Text Key: 161543678
• Report Number: 9166091
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2019,09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: A160620-03 & A150513-07-00-3U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3650 DA
• Patient Weight: 28