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

Model Number	MS1-4570R
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rod has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information has been provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that a rod failed to fully lengthen as intended due to a lead screw fracture.The intended length was not achieved; however, there was no patient adverse event reported.The rod was removed for final fusion.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Device evaluation: the rod was returned for visual and functional testing.X-ray imaging revealed that the thrust bearing was not intact.In addition, sectioning of the rods was performed, which provided additional confirmation of the broken thrust bearing.It also revealed debris buildup which is likely the cause of the device being unable to distract or retract.Functional testing was not performed on the rod.The report of the lead screw breakage was evaluated.It was found to have broken in two pieces and one of the smaller pieces remained in the distraction rod, the other was affixed to the housing tube.The inspection data for the lot for the lead screw was reviewed and the part met design specification.Device history review: a device history review (dhr) was performed on lot number: a16080813 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.Complaint has no change orders (co) or capas.

• 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: 11660828
• Report Number: 3006179046-2021-00228
• Device Sequence Number: 2980619
• Product Code: PGN
• UDI-Device Identifier: 00812258026349
• UDI-Public: 812258026349
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 07/30/2021

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: MS1-4570R
• Device Lot Number: A16080813
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 42