MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number MS1-4570S

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: upon return, visual inspection of the returned magec rod reveled that the rod was distracted beyond the midpoint with some wear/score marks on the distraction rod.The wear/score marks observed on the distraction rod would indicate the distraction rod was extended approximately 24.00 mm from its initial position.The x-ray images of the internal components did not show signs of damage and revealed the rod partially distracted.The rod was functionally tested and was unable to be distracted or retracted with the manual distractor as well as an external remote controller (erc).The rod has therefore determined to be jammed.Sectioning of the rod determined that the distraction rod could not be separated from the housing tube without applying high force which would indicate the distraction rod was likely out of alignment.It is possible, bending forces that were applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube/become out of alignment which could then cause the rod to become jammed.Device records review: a review of the device history records (dhr) indicated that the rod was manufactured by the specified requirements at that time and met all the required quality inspections before shipment.

Event Description

Information was received that removal procedure was performed.There was no reported malfunction or serious injury reported; however, the removed rod was returned to the manufacturer for a device evaluation.During the course of the device evaluation the rod was found to be jammed.

• Brand Name: MAGEC GENERATION 1.5 SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM- MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 15701221
• MDR Text Key: 302723219
• Report Number: 3006179046-2022-00269
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026332
• UDI-Public: 812258026332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161751
• 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
• Report Date: 10/31/2022

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: MS1-4570S
• Device Lot Number: A160519-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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: Prefer Not To Disclose