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

Model Number MC2-6090R

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation.Evaluation was performed by (b)(6).

Event Description

Information was received that a revision procedure was performed on (b)(6) 2018 for an unknown reason.During a review of investigation findings from lirc it was identified that the rod had a pin fracture and a large amount of debris in housing tube.No other information in relation to patient has been reported.

Manufacturer Narrative

The model number and udi number were updated based off the lot number provided.

• 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
• MDR Report Key: 9951842
• MDR Text Key: 190796287
• Report Number: 3006179046-2020-00217
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002114
• UDI-Public: 856719002114
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-6090R
• Device Lot Number: A150519-14-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 76