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

Model Number RA002-5555SLR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

The rod was received and evaluated.During visual inspection, wear/score marks were observed on the distraction rod.Evaluation of the returned rod revealed the distraction rod was functionally able to be distracted and retracted by hand, which indicates a fractured locking pin as the locking pin constrains the axial motion of the distraction rod within the housing tube.The fractured locking pin would allow the distraction rod to "piston" in-situ and this "pistoning" action may allow for debris generation, which could be a contributor to the reported metallosis.No information was provided by the hospital as to whether affected tissue specimens were taken/analyzed; therefore, the reported metallosis cannot be confirmed nor can a cause be determined.The x-rays taken of the returned rod confirmed the fractured locking pin.A definitive cause of the fractured locking pin cannot be determined but may be related to patient daily activities or unique anatomical structure, both of which can influence the amount of force applied to the rod.Inspection data for the lot of locking pin was reviewed and the parts met design specifications per the engineering drawings.As part of the investigation the work order was reviewed, and confirmed the device passed all inspections per the acceptance tests prior to shipment.

Event Description

Information was received that the rod lost connection in the actuator as it was found to be loosening.Additionally, it was reported that metallosis was present.The rod was removed.There was no further adverse patient impact reported.It was reported the rod had been implanted for greater than two years.No additional information is available.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 14723558
• MDR Text Key: 294877553
• Report Number: 3006179046-2022-00184
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002114
• UDI-Public: 856719002114
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SLR
• Device Lot Number: A170315-19-0AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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): Hospitalization
• Patient Sex: Prefer Not To Disclose