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

Model Number RA002-5555SL

Device Problems Corroded (1131); Fracture (1260); Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the (b)(4) implant retrieval centre (lirc); no product was returned to the manufacturer for investigation.A root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that a rod was explanted on an unknown date for an unknown reason.Subsequently, upon review of investigation findings from the (b)(4) implant retrieval centre (lirc), it was identified that the rod exhibited signs of corrosion, galling, and debris present within the housing tube.Further, the rod was unable to retract, and evidence of pin fracture was present.

Manufacturer Narrative

Additional information: no product has been returned for evaluation, however, investigation of the failure revealed that corrosion, surface finish and bending stresses all contribute to pin breaking.A new pin was implemented that had 65% improved strength and significantly improved corrosion resistance.

Event Description

N/a.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. suite 100; aliso viejo CA 92656
• MDR Report Key: 12139742
• MDR Text Key: 260799459
• Report Number: 3006179046-2021-00381
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RA002-5555SL
• Device Lot Number: A120911-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1