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

Model Number MC2-5070R

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

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

No product will been returned to the manufacturer for evaluation.The rods will be sent to newcastle for evaluation.No root cause can be confirmed at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2019.As per reporter the patient was experiencing postoperative infection, fever, and swelling.

Event Description

Additional information was provided.

Manufacturer Narrative

Device evaluation was performed by london implant retrieval centre (lirc).During examination of the rod, the retrieval centre found scratching, discoloration, and mechanical damage.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.

• 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; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 9307530
• MDR Text Key: 166149327
• Report Number: 3006179046-2019-00175
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517834010
• UDI-Public: 887517834010
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MC2-5070R
• Device Lot Number: 7090903AAA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female