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

Model Number	MS1-5590S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	10/11/2022
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 there were signs of metallosis and slight pistoning.The rod has been explanted.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Additional data: b5, h6, h10.The unit was not returned to nuvasive for investigation.This investigation has been conducted by evaluation of provided x-ray image.It was noted that the rod has been distracted beyond the mid-point.There were no obvious device-related abnormalities noted.No objective evidence was found to indicate the presence of metallosis or locking pin failure (slight pistoning).The reported event is unable to be confirmed.The root cause is unable to be determined.Review of the device history records indicated that the unit met all quality specifications and testing prior to product departure.

• 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: 15627092
• Report Number: 3006179046-2022-00255
• Device Sequence Number: 20328388
• Product Code: PGN
• UDI-Device Identifier: 00812258026318
• UDI-Public: 812258026318
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: MS1-5590S
• Device Lot Number: A170217-16
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 34 KG