MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	RA002-5555SL70
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that x-rays revealed that the end cap had disengaged.At this time it is unknown if the patient will undergo a revision procedure.There was no patient injury reported.
Additional Manufacturer Narrative
Updated section e1 for initial reporter.
Additional Manufacturer Narrative
Section d4 was updated to reflect the correct model number and udi.Section e1 was updated to reflect correct hospital name and address.
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 as the device will not be returned per surgeon's decision to forego revision surgery.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.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9771954
• Report Number: 3006179046-2020-00121
• Device Sequence Number: 13999502
• Product Code: PGN
• UDI-Device Identifier: 00812258022648
• UDI-Public: 812258022648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2020

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: RA002-5555SL70
• Device Lot Number: 806212
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/26/2020; 04/01/2020; 09/30/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/26/2020; 04/01/2020; 09/30/2020
• 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