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

Model Number	MS1-4590R
Medical Device Problem Codes	Corroded (1131); Fracture (1260); Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by london implant retrieval centre (lirc).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
An investigation report from an implant retrieval center was received and reported that a revision procedure was performed due to the rod experiencing a pin fracture.During examination of the rod, the retrieval center found corrosion and discoloration on the rod.Additionally, wear, scratches, and other surface damage was noted.There was no further reported patient impact and no patient or user injury was reported.No additional information is available.Report 2 of 2.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Additional data: b5, g3, g6, h2, h6, h10.Report 2 of 2.A review of the dhr documents indicated that the rod was manufactured by the specified requirements and met all of the required quality inspections 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; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 14629723
• Report Number: 3006179046-2022-00195
• Device Sequence Number: 17684356
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: MS1-4590R
• Device Lot Number: A151116-25
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 8 YR
• Patient Sex: Female