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

Model Number	MS1-4590S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and is pending evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon completion of device evaluation.
Event or Problem Description
Information was received that the rod failed to lengthen.No patient adverse event was reported.
Additional Manufacturer Narrative
Corrected data: b1, d4, d9, h1.Additional data: b2, h3, h6, h10.Device evaluation: the returned magec rod was inspected and no damage was found.Score marks were not observed on the distraction rod.X-ray images of the internal components showed no damage and revealed the rod was fully retracted indicating misuse of the electronic remote controller (erc) during the treatment sessions causing device to be retracted instead of being distracted.The unit was jammed by unintentional retraction force.The rod was functionally tested and was unable to distract with manual distractor and erc.The rod was determined to be jammed due to repeated retraction force from improper use of the erc.Device records review: a review of the device history records indicated that the rod was manufactured by the specified requirements at that time and met all of the required quality inspections prior to shipment.Labeling review: ".Do not use this device without proper training in both device implantation and adjustment.Refer to the magec technique guide for step-by-step instructions on the required surgical technique and the external remote controller (erc) operator's manual for operation of the external remote controller." ".Only use the external remote controller in a manner consistent with the operator's manual.Any alternative use may result in injury or damage to property." ".If retraction of the nuvasive specialized orthopedics, inc.Adjustable implant is needed, never retract the implant more than the amount lengthened the previous week.Failure to follow this warning may result in pulling biological material that may have adhered to the rod of the implant into the internal space of the actuator of the implant.".
Event or Problem Description
No additional information was 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, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 12584695
• Report Number: 3006179046-2021-00479
• Device Sequence Number: 11116789
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS1-4590S
• Device Lot Number: 0070110AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 29 KG