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

Model Number	MC2-5590R
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the right side rod has endcap separation.The patient is asymptomatic and the rod is still lengthening.No patient injury has been reported.
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
The unit was not returned to nuvasive for direct investigation.During evaluation of the provided radiographic pictures it was noted that the threaded cap was unthreaded from the housing tube, therefore, the reported failure was confirmed.Additionally, the rod was observed to be distracted approximately beyond the midpoint.The issue recorded in this complaint is a known issue and a corrective action has been implemented.The device history records confirmed the unit was manufactured prior to the implementation of the corrective action.
Event or Problem Description
No additional information has been provided at this time.

• 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, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 15192417
• Report Number: 3006179046-2022-00238
• Device Sequence Number: 12154239
• Product Code: PGN
• UDI-Device Identifier: 00812258022679
• UDI-Public: 812258022679
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 08/30/2022

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: MC2-5590R
• Device Lot Number: 9051501AAA
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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 Sex: Male
• Patient Weight: 28 KG