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

Model Number	MS1-4590S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information has been provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that a revision procedure was performed due to a fracture at the distal end of the rod.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product confirmed the rod was broken therefore the reported failure mode was confirmed.As part of this investigation, functional testing and x-ray did not apply due to the condition of the rod.Because the rod met manufacturing specifications assembly, the breakage did not relate to any manufacturing processes or material issues.The probable root cause of the reported issue is due to the patient's daily activities.Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections prior to release.
Additional Manufacturer Narrative
Updated data.
Event or Problem Description
No additional information was provided.

• 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: 11935704
• Report Number: 3006179046-2021-00293
• Device Sequence Number: 11804486
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2021

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: MS1-4590S
• Device Lot Number: 0070110AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 08/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/12/2021; 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 45