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

Model Number	RA002-4545SLR
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.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 a revision procedure was performed due the rod failing to distract.After the rod was removed, there was visible metallosis and a loose gasket.
Additional Manufacturer Narrative
The investigation revealed a complaint relating to a nuvasive magec rod, 4.5mm 90mm offset ous.The report indicates a revision procedure was performed due the rod failing to distract.After the rod was removed, there was visible metallosis and a loose gasket.There was no patient injury associated with this reported event.No device was returned as it was lost in transit.There was no device available for evaluation, so the reported event was unable to be confirmed.As the device was unavailable, magec force test, and stroke test were not able to be completed.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections upon release to finished goods.Immediate corrective action included replacement of the device.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.Risk document was reviewed and the effects potentially related to the reported event of failed to distract, post-op while using the magec 1/1.5 have been identified and mitigated.A review of the complaint has determined the severity of possible effects from the reported event does not exceed those estimated in the risk documentation.A review of complaints reported event of failure to distract-post op for the magec 1/1.5 device represents a lower occurrence rate compared to the estimated risk associated with this product.No new harm is associated with the reported event.Additionally, based on the risk level estimated for this product, this complaint, as with the previous complaints, does not justify the need for new or additional risk evaluation.
Event or Problem Description
Information was received that a revision procedure was performed due the rod failing to distract.After the rod was removed, there was visible metallosis and a loose gasket.

• Brand Name: MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 19912150
• Report Number: 3006179046-2024-00162
• Device Sequence Number: 18343824
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 00856719002138
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K233593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RA002-4545SLR
• Device Lot Number: 0022104
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 23 KG
• Patient Race: White