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

Model Number MC2-4590S

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and is pending evaluation.The root cause cannot be confirmed at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that the right side rod fractured caudal to the right l2 pedicle screw.Additionally, it was reported that there was blackening of the tissue around the actuator.

Event Description

No additional information has been provided.

Manufacturer Narrative

Device evaluation: upon receipt to nuvasive a visual inspection of the rod was conducted.It was visually confirmed that the rod was broken on the housing body side.It was also observed that the rod was partially distracted with deep scoring marks on the distraction rod.Functional testing was attempted but the rod would not distract.X-rays of the rod do not show any clear component failure, however, it was noted that there was uneven spacing between the distraction rod and housing tube.It is likely that the scoring was a result of the distraction rod rubbing against the threaded cap.For the threaded cap to score the distraction rod external bending force would need to be applied to the actuator.Due to these external bending forces, the distraction rod became scored.It is also possible that exposure to excessive or repeated loading resulted in an unstable construct.Therefore, it is unknown but likely that after implantation, patient activity or weight, could have exceeded loads of the device.Device record review: a review of the device history record (dhr) indicates the rod was manufactured to all specified requirements at the time and met all the required inspections prior to 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, 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: 17398277
• MDR Text Key: 320163905
• Report Number: 3006179046-2023-00313
• 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: K171791
• 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
• Report Date: 10/03/2023

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
• Device Operator: Health Professional
• Device Model Number: MC2-4590S
• Device Lot Number: 8082309AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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: Male
• Patient Weight: 26 KG