MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. 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	Pain (1994); Skin Discoloration (2074); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
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 during the patient's expansion appointment it was noted that there was little to no expansion of the rod and the rod became so prominent it appeared it was going to pop out of the skin.The hardware had become prominent which caused skin tenting and was blanching the patient's skin in the back region.Additionally, the patient began experiencing increased laxity in their hands and wrist.The patient experienced pain in the midback and their skin had become opaque.There was heterotropic ossification partially surrounding the right rod from t8 to t12 with greater than 180 degree involvement around the t9 to t11 level.Degenerative changes in the facets without osseous fusion of l3-l4 and osseous fusion of the bilateral l2-l3 facets.The patient was found to have rod pull out proximally and was experiencing poor lung function.The proximal screws in the rod had little to no purchase and the patient's spine had autofused from t4 all the way up to the c7 level.The patient underwent a revision surgery to replace the rods.There were no intraoperative complications.No additional information is available.This is report 2 of 2.

• 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: 13614936
• Report Number: 3006179046-2022-00129
• Device Sequence Number: 14708454
• 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
• Device Explanted Year: 2020
• 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: UNKNOWN
• 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-4.2X25MM SCREW, LOT 0203 09DEC2019; DEPUY-5.2X30MM SCREW, LOT 0203 09DEC2019; DEPUY-5.2X40MM SCREW, LOT 0203 09DEC2019; DEPUY-COLLAR, LOT 0203 09DEC2019; DEPUY-DISTRACTION LOCK, 0206 01AUG2019; DEPUY-NUT, LOT 0203 09DEC2019; DEPUY-SIZE 6 220MM DISTAL EXTENSION; DEPUY-SIZE 6 220MM PROX. EXTENSION; DEPUY-SIZE 7 220MM DISTAL EXTENSION; DEPUY-SIZE 7 220MM PROX, EXTENSION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female