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

Model Number MC2-5570S

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

Information was received that the rod could not be distracted anymore.No patient adverse event was reported.

Manufacturer Narrative

Updated section: the nail was received for visual inspection and functional testing.Upon return, visual inspection of the rod revealed evidence of discoloration.In addition, examination of the rod showed there was an attempt made to distract before it reportedly stopped to distract.This could happen if the rod was jammed if it was tried to retract back too much.Per reported failure, functional testing was not possible.X-ray images of the rod reveal that the retainer ring that should be position inside the groove is out of position.This could even prevent any rotation of magnet itself.This confirms that the rod is jammed which is the reason behind its failure to distract.A device history review (dhr) was performed on lot number 9021405 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.

Event Description

No additional information provided.

• 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 dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 12477669
• MDR Text Key: 271686109
• Report Number: 3006179046-2021-00458
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• 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: 10/28/2021

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: MC2-5570S
• Device Lot Number: 9021405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1