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

Model Number RA002-5555SL

Device Problem No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation as it was returned to the (b)(6).Root cause is unable to be determined.The reported event has been addressed in the device labeling.

Event Description

It was reported that a revision procedure was performed on an unknown date for a final fusion.There was no patient injury reported.During a review of investigation findings from (b)(6) the rod had a pin fracture and debris in housing tube.

• 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 11102145
• MDR Text Key: 224596513
• Report Number: 3006179046-2020-00551
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: A150728-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 9 YR