MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number	MS1-5590S
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.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
Information was received that upon explant what appears to possibly be corrosion or calcified tissue/blood was noted on the rod.No additional information has been provided at this time.
Additional Manufacturer Narrative
Additional data: b5, b6, d4, e1, e2, e3, h4, h6, h10.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.
Event or Problem Description
Additional information has been provided.
Additional Manufacturer Narrative
Additional data: b5, h6, h10.The magec rod has not been returned for an in-person evaluation.This investigation has been conducted based on provided images of the rod after removal surgery.The image reveals the rod was partially distracted with some wear/score marks on the distraction rod.Visible evidence of discoloration (corrosion) was noted at the junction of the distraction rod and housing tube which confirmed the reported failure.The large amount of the visible material is seemingly inconsistent with the relatively mild debris of surface damage noted, indicating that the majority of this debris was biologic in origin and likely bone-like material.
Additional Manufacturer Narrative
Additional data: d9, h3, h6, h10.Device evaluation: the rod has been received for in-person evaluation.Visual inspection of the returned rod revealed the rod was partially distracted with score marks on the distraction rod which indicate the rod was extended approximately 26 mm.No biologic material can been seen on the distraction rod.Likely all of the possible biologic material such as blood, bone-like material and tissue which were visible on the provided image has been wiped clean.Review of the work order revealed that the rod was visually inspected and functionally tested prior to release and met all the required quality inspections.Based on this investigation no sign of corrosion was discovered.The reported failure was initially confirmed based on provided image, however, once the rod was physically returned discoloration was not present once the blood/material was cleaned off for investigation.
Event or Problem Description
No additional information has been provided.
Event or Problem Description
No additional information has been provided.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 15886309
• Report Number: 3006179046-2022-00277
• Device Sequence Number: 20103321
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K201543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2023

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: MS1-5590S
• Device Lot Number: A161010-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 11/30/2022; 12/28/2022; 02/21/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/07/2022; 12/30/2022; 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2016
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose