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

Model Number	MS1-5590R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Information was received that the rod failed to distract.No patient adverse event was reported.
Event or Problem Description
No additional information has been provided.
Additional 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.
Additional Manufacturer Narrative
Corrected data: d4 (model number and udi number) additional data: b5, d9, h3, h6, h10.
Event or Problem Description
No additional information has been provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: 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
• Report Number: 3006179046-2022-00181
• Device Sequence Number: 3986173
• Product Code: PGN
• UDI-Device Identifier: 00812258026325
• UDI-Public: 812258026325
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 06/16/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/26/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 45 KG