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

Model Number	RA002-4545SLR70
Medical Device Problem Codes	Corroded (1131); Fracture (1260); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the (b)(4) implant retrieval centre (lirc); no product was returned to the manufacturer for investigation.A root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a rod was explanted on an unknown date for an unknown reason.Subsequently, upon review of investigation findings from the london implant retrieval centre (lirc), it was identified that the rod exhibited signs of corrosion, galling, and debris present within the housing tube.Further, the rod was unable to retract, and evidence of pin fracture was present.
Event or Problem Description
N/a.
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.

• 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: 12139799
• Report Number: 3006179046-2021-00384
• Device Sequence Number: 19827286
• Product Code: PGN
• UDI-Device Identifier: 00856719002145
• UDI-Public: 856719002145
• 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: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: RA002-4545SLR70
• Device Lot Number: A140308-01
• 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: 07/28/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1