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

Model Number	RA002-5555SL70
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.
Event or Problem Description
Information was received that a revision procedure was performed on an unknown date.As per the reporter, the rod locked in-situ.No patient injury was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The rods were returned for visual and functional testing.X-ray images of the rods revealed that both had a broken radial bearing, broken cage and the inner/outer races were misaligned.Functional testing was performed and the rods were unable to distract or retract with the electronic remote controller (erc) and manual distractor.Sectioning of the rods confirmed that the radial ball bearings were broken.In addition, the sectioning of the rods revealed hardened debris was buildup.The root cause if the reported event was unable to be determined.A device history review (dhr) was performed on both rods lot number a170214-19 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.

• 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: 11397125
• Report Number: 3006179046-2021-00165
• Device Sequence Number: 3381608
• Product Code: PGN
• UDI-Device Identifier: 00856719002152
• UDI-Public: 856719002152
• Combination Product (Y/N): N
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: RA002-5555SL70
• Device Lot Number: A170214-19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization