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

Model Number MC2-4590S

Device Problems Corroded (1131); Migration or Expulsion of Device (1395); Structural Problem (2506); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Failure of Implant (1924)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as product remains in-situ.Radiograph provided confirms customers alleged event.

Event Description

Information was received that during the patient's second lengthening, x-ray images revealed the end cap had disengaged from the rod.There is no revision planned at this time.No patient injury was reported.

Manufacturer Narrative

Device is being returned to lirc.

Event Description

Updating report as revision procedure was performed on (b)(6) 2020.

Manufacturer Narrative

No product has been returned for evaluation as it was returned to newcastle engineering lab.Radiographs provided confirmed the alleged event.Even though no product has been returned, fsca investigation was performed and variation in the torque applied to the threaded cap during the assembly process was identified as the root cause of the failure.Per the manufacturing instructions, the threaded cap must be tightened to 40 in-lbs.Although all operators followed the assembly procedure, and the torque wrench indicated 40 in-lbs was applied, the manner of using the torque wrench resulted in variances in applied torque.The manner in which the operator handles the torque wrench may impact the actual torque applied to the end cap, thereby creating a false positive that the specified torque has been applied.If the specified torque is not applied, the effectiveness of the cap tightening process may be compromised.

Event Description

The device was sent to newcastle university engineering lab for evaluation who reported that the rod was not force tested as the end cap was disengaged.With the end cap and its sealing o-rings not in position, the sealing mechanism was compromised.The internal components were noted to be covered with rust-colored debris.The radial bearing was in position, however, it could not rotate as it was seized to the magnet.Therefore, the leadscrew could not be separated from the magnet.No further disassembly was possible, therefore, the drive pin was unable to be analyzed.

Manufacturer Narrative

A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.

• Brand Name: MAGEC SYSTEM
• Type of Device: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 10136025
• MDR Text Key: 194664070
• Report Number: 3006179046-2020-00329
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517944313
• UDI-Public: 887517944313
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-4590S
• Device Catalogue Number: MAGEC 2 ROD, 4.5MM 90MM OFFSET
• Device Lot Number: 9022204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1898-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 26 KG