MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED 1 MAGEC SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number	MS1-4590S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were radiographs or images provided to confirm the alleged failure.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a revision procedure was completed on (b)(6) 2020.As per reporter, the rod was jammed.
Event or Problem Description
This report has been updated to include investigation findings.
Additional Manufacturer Narrative
Investigation findings: the rod was received for visual and functional testing.Visual inspection revealed score marks observed on the distraction rod due to incremental distraction.Functional testing revealed that the rod was unable to distract with manual distractor but it distracted with the electronic remote controller (erc).The reported failure mode was unable to be confirmed as the rod was fully functional and met acceptance test specifications.

• Brand Name: MAGEC SYSTEM
• Common Device Name: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED 1; 101 enterprise; aliso viejo CA 92656
• MDR Report Key: 9729120
• Report Number: 3006179046-2020-00107
• Device Sequence Number: 19451387
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: MS1-4590S
• Device Lot Number: A160301-09
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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: 11 YR