MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC® SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number	MC2-5070S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as it was returned to london implant retrieval center (lric).No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2019.As per the reporter, the rod was removed due to infection.Implantation date: (b)(6) 2019, date of revision: (b)(6) 2019.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Information was received that confirms that the initial report mfr # 3006179046-2020-00151, submitted on march 13, 2020, is a duplicate of mfr # 3006179046-2020-00327.Report mfr # 3006179046-2020-00151 is not needed.Any additional information for the reported event will be submitted under mfr # 3006179046-2020-00327.

• Brand Name: MAGEC® SYSTEM
• Common Device Name: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; brockley hill, stanmore
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656
• MDR Report Key: 9831501
• Report Number: 3006179046-2020-00151
• Device Sequence Number: 13644396
• Product Code: PGN
• UDI-Device Identifier: 00887517834027
• UDI-Public: 887517834027
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: MC2-5070S
• Device Lot Number: 7090516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female