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

Model Number	MC2-5070S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/02/2020
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 pertinent additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the end cap was disengaged from the left side rod.Normal wear debris was found on the rod during explant.No patient harm was reported.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: upon return, visual inspection of the magec rod revealed the end cap disengagement.The end cap disengagement is a previously known failure that can occur due to insufficient torque being applied to the end cap during assembly.Review of work order revealed the rod passed inspection.Per reported failure, functional testing was not applicable.Device records review: device history records reveal that the rod was visually inspected and functionally tested prior to release.
Additional Manufacturer Narrative
Device evaluation: review of manufacturing records found the device met all release criteria.Visual inspection and x-ray images of the returned product confirmed the end cap was unthreaded from the housing tube.This issue was previously identified and addressed through the capa process, and communicated through field action z-1898-2020.
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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 12051995
• Report Number: 3006179046-2021-00317
• Device Sequence Number: 14558903
• Product Code: PGN
• UDI-Device Identifier: 00887517834027
• UDI-Public: 887517834027
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2021

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: MC2-5070S
• Device Lot Number: 8041114AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• 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: 05/28/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 12/09/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 10/11/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2018
• 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
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 18 KG