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

Model Number MC2-5070S

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has been received and is pending evaluation.The root cause is unable to be determined at this time.A supplemental report will be submitted following the evaluation.

Event Description

Information was received that the rod was not lengthening.No patient harm was reported.

Event Description

No additional information was provided.

Manufacturer Narrative

Additional data: h3, h6, h10 corrected data: d4 (lot number),g4, h6 (impact code & clinical code) device evaluation: visual inspection of the returned rod showed score marks on the distraction rod.The rod was unable to be distracted with the manual distractor and external remote controller (erc).Additionally, the rod was unable to be retracted with fast distractor.X-ray images of the internal components revealed a broken cylinder magnet.The reported failure was therefore confirmed as the rod was not able to be distracted or retracted.The exact root cause for the cylinder magnet fracture is unknown.Device records review: review of the device history records revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections before shipment.

Event Description

No additional information has been provided.

Manufacturer Narrative

Additional device evaluation: measurements of the score marks confirmed the distraction rod was extended approximately 9mm from its initial position.The inspection data for the cylinder magnet (lot#171121-11) has been reviewed and confirmed the part met design specifications per the engineering drawings.Magnet fracture is a known inherent risk of the device.The exact root cause of the broken cylinder magnet is unable to be determined, however, the following possible root causes have been identified: the titanium casing was insufficient to protect magnet from loading; improper assembly of the magnet module resulting in unintended loading of the magnet; failure of the epoxy bond resulting in unintended loading of the magnet.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 12161227
• MDR Text Key: 262562027
• Report Number: 3006179046-2021-00407
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517834027
• UDI-Public: 887517834027
• 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
• Report Date: 08/23/2022

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
• Device Operator: Health Professional
• Device Model Number: MC2-5070S
• Device Lot Number: 7121602AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 05/19/2022; 08/17/2022
• Supplement Dates FDA Received: 06/17/2022; 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 37 KG