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

Model Number MS1-5590R

Device Problem Mechanical Problem (1384)

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

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 failed to distract.No patient adverse event was reported.

Event Description

No additional information has been provided.

Manufacturer Narrative

Additional data: h3, h6, h10 device evaluation: upon return, visual inspection of the returned rod revealed the rod was partially distracted with score marks consistent with expected markings due to incremental distraction.The wear/score marks observed on the distraction rod indicate the distraction rod was extended approximately 4 mm from its initial position.X-ray images of the internal components showed no damage and revealed the rod was partially distracted.The rod was functionally tested and was unable to distract and retract with the manual distracter as well as the external remote controller (erc).The rod was therefore determined to be jammed.The rod was then sectioned and titanium debris build up was found which may have caused the reduced functionality of the rod.Sectioning of the rod determined that the rod could not be separated from the housing without use of high force applied which means possible bending forces had been applied to the rod from patient anatomy/activity which then may have caused the distraction rod to wedge into the housing tube, then causing the rod to jam.Device records review: review of the device history records (dhr) revealed the rod was manufactured in accordance with the specified requirements and met all of the required quality inspections prior to release.

Manufacturer Narrative

Corrected data: d4 (model number and udi number) additional data: b5, d9, h3, h6, h10.

Event Description

No additional information has been 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 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: 14145388
• MDR Text Key: 290113788
• Report Number: 3006179046-2022-00181
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026325
• UDI-Public: 812258026325
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-5590R
• Device Lot Number: A171204-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 45 KG