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

Model Number	MC2-4570S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is pending 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 wouldn't lengthen during testing.No patient adverse event was reported.
Additional Manufacturer Narrative
Device evaluation: upon return, visual inspection of the magec rod revealed the distraction rod was fully retracted.X-ray images of the internal components showed no obvious damage.The rod was functionally tested and during testing the rod was able to be distracted and retracted with the external remote controller (erc) as well as the manual distractor.The length as received was measured at 473.93 mm.The minimum and maximum lengths were measured at 473.93mm and 500.97 mm, respectively, giving a total stroke measurement of 27.04 mm which meets the specification.Distraction force testing was measured at 47.65 lbs, which meets the specification.The reported failure was unable to be confirmed as the device met all specifications.Device records review: a review of the device history records (dhr) indicated that the rod has been manufactured by the specified requirements and met all of the required quality inspections before shipment.
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 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: 14137445
• Report Number: 3006179046-2022-00173
• Device Sequence Number: 20394818
• Product Code: PGN
• UDI-Device Identifier: 00812258022600
• UDI-Public: 812258022600
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K201543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: MC2-4570S
• Device Lot Number: 1022303AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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 Sex: Prefer Not To Disclose