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

Model Number	RA002-4545SLR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by (b)(6).If additional relevant information is obtained, then a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a revision procedure was performed on an unknown date for an unknown reason.During a review of investigation findings from lirc evidence of pin fracture was observed on the rod, galling and corrosion.Additionally it was observed that the rod was unable to be retracted.
Additional Manufacturer Narrative
Additional information: no product has been returned for evaluation, however, investigation of the failure revealed that corrosion, surface finish and bending stresses all contribute to pin breaking.A new pin was implemented that had 65% improved strength and significantly improved corrosion resistance.
Event or Problem Description
No additional information.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise #100; aliso viejo CA 92656
• MDR Report Key: 12132067
• Report Number: 3006179046-2021-00359
• Device Sequence Number: 11966116
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• 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,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: RA002-4545SLR
• Device Lot Number: A140212-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1