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

Model Number	MS1-5570S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that after the initial surgery, the rods only lengthened once and the patient experienced pain in the lower back.During a follow up visit, it was noted that the magec rod had become prominent in the upper back.Additionally, it was reported that there was increased lucency surrounding the l3 and l4 pedicle screws the patient underwent a revision procedure due to upper bilateral laminar hooks dislodging.The patient's spine was fused from t2 to t4 and allograft was placed.The surgeon replaced the proximal hooks with pedicle screws to better hold the rod.There were no patient intraoperative complications.Two rods were involved in the complaint.This is report 1 of 2 for this event/patient.
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.Device records review: review of the device history record for the rod confirmed that it met all of the required quality inspections.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise #100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise #100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 13608188
• Report Number: 3006179046-2022-00128
• Device Sequence Number: 1930923
• Product Code: PGN
• UDI-Device Identifier: 00812258026356
• UDI-Public: 812258026356
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: MS1-5570S
• Device Lot Number: A150220-02-00-02U
• Was Device Available for Evaluation?: No
• 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: 02/01/2022
• Initial Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY-POLY SCREW 4.35X25 LOT 179712625; DEPUY-POLY SCREW 4.35X30 LOT 179712460; DEPUY-POLY SCREW 5.0X25 LOT 179712525; DEPUY-SET SCREW LOT 179702000
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 10 YR
• Patient Sex: Female