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

Model Number	MC2-4590S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximate implant date reported as 2019 and approximate explant date reported as (b)(6) 2021.The device has been received and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted following the device evaluation.
Event or Problem Description
Information was received that the rod failed to reach terminal distraction lengthen.The rods were removed for final fusion with a competitor product.No patient adverse event was reported.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Upon return, visual inspection of the rod revealed that it was partially distracted with score marks consistent with expected markings due to incremental distraction.X-ray images of the internal components of the rod revealed that the retaining ring, that should be positioned inside the groove, was out of position.To perform a thorough inspection of the inside of the housing, the rod was sectioned and the housing tube was inspected for any damage near the retaining ring groove.The sectioning revealed the housing tube displayed some damage (scratches) around the groove and above it, which confirms the retaining ring was forced out of its groove.This can possibly occur if excess tensile loading was applied to the retaining ring due to patient activities.Lastly, the rod was functionally tested and was unable to distract or retract utilizing the electronic remote controller (erc) or the manual distractor.The rod was confirmed to be jammed as the retaining ring inside the rod was misaligned, preventing the magnet's rotation.The device history records were reviewed, and found the device was manufactured in accordance with the specified requirements and met all the required quality inspections.There were no discrepancies or non-conformances related to the reported event.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13162943
• Report Number: 3006179046-2022-00105
• Device Sequence Number: 14805606
• Product Code: PGN
• UDI-Device Identifier: 00812258022624
• UDI-Public: 812258022624
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: MC2-4590S
• Device Lot Number: 8082718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2018
• 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 Sex: Female