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

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

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.

Event Description

No additional information has been provided.

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 Description

Additional information has been provided.

Manufacturer Narrative

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 16 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 Description

No additional information has been provided.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: 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: 15886252
• MDR Text Key: 304881801
• Report Number: 3006179046-2022-00276
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose