MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; ORTHOPEDIC INTERNAL FIXATION SYSTEMS, SPINAL

Model Number	MC2-5590S
Medical Device Problem Codes	Corroded (1131); Structural Problem (2506); Failure to Advance (2524); Detachment of Device or Device Component (2907); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as it will be returned to new castle engineering lab.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that x-ray images revealed that the end cap had disengaged from the rod.It is unknown if a revision procedure is planned.There was no patient injury reported.
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.Radiographs provided confirmed the alleged event.Even though no product has been returned, fsca investigation was performed and variation in the torque applied to the threaded cap during the assembly process was identified as the root cause of the failure.Per the manufacturing instructions, the threaded cap must be tightened to 40 in-lbs.Although all operators followed the assembly procedure, and the torque wrench indicated 40 in-lbs was applied, the manner of using the torque wrench resulted in variances in applied torque.The manner in which the operator handles the torque wrench may impact the actual torque applied to the end cap, thereby creating a false positive that the specified torque has been applied.If the specified torque is not applied, the effectiveness of the cap tightening process may be compromised.
Event or Problem Description
The device was sent to newcastle university engineering lab for evaluation who reported that the rod was tested in a jig with an external remote controller (erc) and did not exert any force during testing.The end cap was found to be out of position prior to disassembly of the rod and the extending bar was covered with rust-colored debris.Clearly, with the end cap and its sealing o-rings not in position, the sealing mechanism was compromised.The internal o-ring seal was intact but slightly damaged and the leadscrew was seized inside the extending bar.No additional information is available.
Additional Manufacturer Narrative
Additional data: b5, b6, d9, g2, h6, h10 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.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: ORTHOPEDIC INTERNAL FIXATION SYSTEMS, SPINAL
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.V; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656
• MDR Report Key: 9765878
• Report Number: 3006179046-2020-00119
• Device Sequence Number: 618332
• Product Code: PGN
• UDI-Device Identifier: 00812258022662
• UDI-Public: 812258022662
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2023

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: MC2-5590S
• Device Lot Number: 8062511AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 02/01/2023
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 01/07/2021; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1898-2020
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Male