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

Model Number MC2-4570S

Device Problems Mechanical Jam (2983); Naturally Worn (2988); Scratched Material (3020)

Patient Problem Pain (1994)

Event Date 10/14/2021

Event Type  Injury  

Event Description

An investigation report from an implant retrieval center was received and reported that a revision procedure was performed due to unexpected pain.During examination of the rod, the retrieval center found the rod would not distract.Additionally, discoloration, wear, scratches, and other surface damage was noted.There was no further reported patient impact and no patient or user injury was reported.No additional information is available.Report 2 of 2.

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by (b)(4).The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Manufacturer Narrative

Additional data: b5, g3, g6, h2, h6, h10.Report 2 of 2.A review of the dhr documents indicated that the rod was manufactured by the specified requirements and met all of the required quality inspections prior to shipment.

Event Description

No additional information was provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 14629734
• MDR Text Key: 293524567
• Report Number: 3006179046-2022-00197
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022600
• UDI-Public: 812258022600
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-4570S
• Device Lot Number: 8061106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 9 YR
• Patient Sex: Male