MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number MC2-4590S

Device Problem Failure to Advance (2524)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Information was received that a revision procedure was performed due to the rod meeting maximum distraction length.The was no reported issue with the rod as it was rod was reportedly intact.The patient was converted to definitive fusion and had no history of trauma/accidents.No additional information has been provided.During the investigation of the returned rod revealed that it failed to distract.

Manufacturer Narrative

Upon receiving the device, a visual inspection was performed.The device was received in one piece.There was notable galling on the distraction rod.The distraction rod was also observed to be off center to the housing tube and has debris on the side with the gap.In-house x-ray showed no damage to the internal components.Functional testing was attempted with both a manual distractor and fast distractor but was unsuccessful.Sectioning the device revealed titanium shavings from the distraction rod rubbing on the housing.The debris had infiltrated the thrust bearing ceasing it up, making it difficult to move with either distractor.There was no complaint against this specific device, but secondary findings showed that the device was non-functional due to wear debris inside of the rod.A review of the dhr documents indicates the device was manufactured by the specified requirement at the time and met all the required inspections before shipment.

• Brand Name: MAGEC GENERATION 2B SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 18965572
• MDR Text Key: 338728101
• Report Number: 3006179046-2024-00119
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022624
• UDI-Public: 812258022624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K233593
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-4590S
• Device Lot Number: 9061819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 32 KG