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

Model Number	MS1-4570S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the returned rod was observed to be partially distracted with score marks on the distraction rod.X-ray images of internal components showed no obvious damage and revealed the rod was partially distracted.The rod was functionally tested and could not distract and retract with the electronic remote controller (erc) and the manual distractor.Because the rod was unable to retract or distract, force testing and the stroke measurement test could not be performed.Sectioning of the rod revealed the distraction rod was contacting the internal surface of the housing.The two components could not be separated without applying high force.After applying high force, the two components they were able to be separated.The potential root cause of the reported event was due to patient activity causing the distraction rod to become bent causing a jam.Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections prior to shipment.
Event or Problem Description
Information was received that a revision surgery was performed due to the surgeon believing that the rods were not deploying due to extended time between distractions.No patient harm was reported.

• 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: 11995933
• Report Number: 3006179046-2021-00309
• Device Sequence Number: 11558081
• Product Code: PGN
• UDI-Device Identifier: 00812258026332
• UDI-Public: 812258026332
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: MS1-4570S
• Device Lot Number: A150520-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1