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 Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Low Oxygen Saturation (2477); Blood Loss (2597)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that during fluoroscopy it was observed that the end cap was disengaged from the rod.As per reporter, a revision procedure is planned.
Event or Problem Description
Received information stating the revision procedure was extended due to surgical complications.Patient was taken to the intensive care unit (icu) instead of general ward.
Additional Manufacturer Narrative
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
Additional information provided: d4, h6, h7 h9, h10.

• 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; suite 100; aliso viejo CA 92656
• MDR Report Key: 9246070
• Report Number: 3006179046-2019-00168
• Device Sequence Number: 1879467
• Product Code: PGN
• UDI-Device Identifier: 00812258022600
• UDI-Public: 812258022600
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2021

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 Catalogue Number: PA0684-007
• Device Lot Number: 8061809
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 11/18/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/18/2019; 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STRYKER XIA SCREW SYSTEM.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 7 YR