MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC GENERATION 1 SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM- MAGNETIC ACTUATION

Model Number	RA002-4545SLR
Medical Device Problem Codes	Break (1069); Degraded (1153); Mechanical Problem (1384); Structural Problem (2506); Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Evaluation was performed by newcastle engineering lab.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
It was reported that when the rod was removed from the patient there was obvious pistoning/movement in the rod which may have been brought on by the use of force and the mallet.An investigation report from an implant retrieval center was received and reported that during examination of the rod, the retrieval center found the rod exerted no force during force testing.Additionally, the rod was unable to be further disassembled and the drive pin was unable to be examined.The o-ring was found to be damaged as it was noted to be thinner and it was deemed to be compromised.Due to the compromised sealing mechanism, debris was observed on the components.No additional information is available.
Event or Problem Description
No additional information has been provided.
Additional Manufacturer Narrative
Updated section: h6- component codes and device code.
Additional Manufacturer Narrative
Corrected section h6- device code.
Event or Problem Description
No additional information provided.

• Brand Name: MAGEC GENERATION 1 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: 16358858
• Report Number: 3006179046-2023-00127
• Device Sequence Number: 6803861
• Product Code: PGN
• UDI-Device Identifier: 00856719002138
• UDI-Public: 856719002138
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2023

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: RA002-4545SLR
• Device Lot Number: A131203-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/13/2023; 02/01/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 02/13/2023; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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
• Patient Age: 16 YR
• Patient Sex: Male