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

Model Number	RA002-4545SL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that the rod was not distracting.The patient had received left and right rods and both successfully distracted during the first lengthening session.However, during subsequent lengthening sessions, the right rod did not distract.A revision surgery is planned.There were no reported problems with the left rod.No additional information is available.
Additional Manufacturer Narrative
Additional data.
Event or Problem Description
No additional info was received.
Additional Manufacturer Narrative
Device evaluation: the returned rod was observed to be partially distracted with some scratch marks on the distraction rod indicating resistance during distraction.X-ray images of internal components showed no obvious damage and revealed the rod was partially distracted.The rod was functionally tested and was able to distract and retract with the manual distractor.The rod was able to retract and distract with fast distractor to perform stroke test.The maximum and minimum length were measured at 342.44mm and 293.85mm respectively; giving a total stroke measurement of 48.59mm, which meets the 48±1mm specification.The work order was reviewed and confirmed the rod passed all inspections.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections.Device records review: a review of device history records for the returned unit confirmed that it met all the required quality inspections prior to release.
Event or Problem Description
Corrected device 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: 12132597
• Report Number: 3006179046-2021-00366
• Device Sequence Number: 17182321
• Product Code: PGN
• UDI-Device Identifier: 00812258026301
• UDI-Public: 812258026301
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/14/2021

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: RA002-4545SL
• Device Lot Number: 0030401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/06/2021; 09/15/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/20/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR