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

Model Number RA002-5555SL

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

The rod was received for visual and functional testing and the reported event was confirmed as the device was jammed.The root cause of the reported event may be related to bending force applied during the distraction sessions and/or patient's daily activities.The distraction rod rubbing against the housing tube from the patient's activity would cause debris buildup, which would cause the device to jam.Review of the device history record for the returned rod and confirmed that it met all of the required quality inspections.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2016.As per the reporter, the rods were removed for converting to final fusion and appeared to be jammed.The patient successfully completed treatment and lengthening sessions without issues; however, during the last distraction session, the rod did not appear to lengthen.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 10575409
• MDR Text Key: 208192805
• Report Number: 3006179046-2020-00397
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002190
• UDI-Public: 856719002190
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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: A130116-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2013
• 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: 14 YR
• Patient Weight: 38