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

Model Number MS1-4590S

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

It was reported that the rod was explanted because it would no longer lengthen.No patient adverse event was reported.

Manufacturer Narrative

Device evaluation: upon return, visual inspection of the rod revealed score marks on the distraction rod.X-ray images of the internal components showed no obvious damage and revealed the rod was partially distracted.The rod was unable to be distract with manual distractor & external remote controller (erc).The rod was sectioned to allow access to internal components, revealing some debris within, which appeared to be a combination of titanium debris and lubricant.Rod sectioning also revealed the distraction rod was contacting the internal surface of the housing.The two components could not be separated without the use of high force, indicating bending force were applied to the distraction rod causing it to go out of alignment and contact the housing.This is likely a result of patient activity and weight bearing.Device records review: review of the device history records revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections prior to release.Labeling review: ".During period of implant, patient should not participate in contact or severe sports or other high risk activities." ".Patients should be limited to those having a bmi of 52 or less.".

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; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 12896743
• MDR Text Key: 282727869
• Report Number: 3006179046-2021-00505
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-4590S
• Device Lot Number: A180103-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 12/29/2021
• Supplement Dates FDA Received: 11/30/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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 Sex: Male