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

Model Number MS1-5590S

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that allegedly the patient's magec rods were not distracting after over three (3) years of implantation.The physician revised the magec rods with new rods without incident.

Event Description

Rods were explanted because they stopped lengthening.We re-implanted new magec rods (magec x).Implant date: (b)(6) 2015, explant date: (b)(6) 2019.

Manufacturer Narrative

A visual inspection of the returned rods revealed to be partially distracted.The rods were functionally tested and could only be partially distracted and retracted using the erc.The rods were unable to be distracted using the manual distractor.The rods were cut open and debris build up was found, which may have caused the reduced functionality.A review of the lot history record for the rods revealed that they met all of the required quality inspections and that the products were released within specifications.

• 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, suite 100; aliso viejo CA 92656
• MDR Report Key: 8426963
• MDR Text Key: 139037748
• Report Number: 3006179046-2019-00107
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MS1-5590S
• Device Catalogue Number: PA0518
• Device Lot Number: A150415-11, A150513-07
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 60