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

Model Number	MC2-4570R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the (b)(6) for evaluation.Root cause is unable to be determined.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date due to a broken rod.During a review of investigation findings from lirc it was identified that the rod was broken.
Additional Manufacturer Narrative
Correction: b5, h6.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date due to a broken rod.During a review of investigation findings from lirc it was identified that there was no problem found.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11397104
• Report Number: 3006179046-2021-00159
• Device Sequence Number: 3381603
• Product Code: PGN
• UDI-Device Identifier: 00812258022617
• UDI-Public: 812258022617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC2-4570R
• Device Lot Number: 8063011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization