MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number RA002-5555SL

Device Problem Failure to Advance (2524)

Patient Problem Failure of Implant (1924)

Event Date 09/11/2023

Event Type  Injury  

Event Description

Information was received that during the device evaluation the rod was not distracting.

Manufacturer Narrative

Device evaluation: the rod was returned to nuvasive for evaluation.Upon receipt of the device, a visual inspection was conducted and score marks were observed on the distraction rod which is typically associated with periodic distraction.In-house device x-rays determined that the radial bearing was broken.Functional testing was attempted, but the rod was not distracting or retracting, therefore, the reported failure was confirmed.The device was then sectioned and confirmed that the radial bearing was broken and the o-ring was torn.This torn o-ring could have been caused by the force that created the scoring marks.If the o-ring seal was compromised, that could have led to the degradation of the bearing, which ultimately broke and caused the failure to distract.Device record review: a review of the device history record (dhr) indicates the device was manufactured by the specified requirement at the time and met all the required quality inspections and specifications prior to shipment.If any additional information is provided, a supplemental report will be submitted.

Event Description

No additional information has been provided.

Manufacturer Narrative

There was observable debris between the interface of the distraction rod and the housing body.Sectioning of the rod was performed and it visually confirmed the broken bearing.Sectioning also revealed a significant amount of black debris, likely titanium, in the housing body.The o-ring was also observed damaged/torn and one side of the rod was shinier than the other as the anodization was rubbing off.A closer look at the rod¿s anti-rotation tabs found one was completely worn.The root cause of the failure to distract event is unable to be determined, however, it is likely that the debris found surrounding the bearing made it seize and break.When it is coupled with the debris in the housing tube causing frictional forces between the two sliding surfaces of the rod, it would allow for the housing tube to impede distraction.

• Brand Name: MAGEC GENERATION 1.5 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: 18602802
• MDR Text Key: 334028942
• Report Number: 3006179046-2024-00110
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SL
• Device Lot Number: 0110922AAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female