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 Structural Problem (2506)

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 left side rod's o-ring was displaced in 2019.Additionally, it was reported that there was blackening of the tissue around the actuator.

Manufacturer Narrative

Device evaluation: upon receipt to nuvasive a visual inspection of the rod was conducted.It was visually confirmed that the thread cap had disengaged from the housing body.It was also observed that the rod was partially distracted with some slight discoloration on the distraction rod which may be related to the reported blackening of the skin around the actuator.The blackened tissue was unable to be confirmed as no objective evidence was provided.No scoring marks or scratches were observed on the outer surface of the device.X-rays were taken of the rod and found that the retaining ring was out of the housing body groove.Per the risk file, if there is inadequate engagement between the retaining ring and the housing body groove that could potentially lead to a device failing to distract.This failure was observed when attempting to distract the rod with a fast distractor and no distraction could be achieved.The root cause is likely that the design was insufficient to prevent the threaded cap from separating.A corrective and preventive action (capa) was initiated to address the design failure.Based on the investigation conducted in the capa, the design was insufficient to prevent the cap from separating.Since this rod was manufactured prior to the implementation of this capa it is possible that the design was insufficient to prevent the separation that was reported.It should be noted that this rod was manufactured in 2019 prior to the implementation of the capa.Device record review: a review of the device history record (dhr) indicates the rod was manufactured by the specified requirement at the time and met all the required inspections before shipment.

Event Description

No additional information has been provided.

• 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: 17398263
• MDR Text Key: 320241107
• Report Number: 3006179046-2023-00312
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• 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: 9011812AAA
• 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
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2019
• 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