MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE-L; LATERAL INSERTER

Model Number	693.601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation found the threaded distal end of the inner shaft has sheared at the base of the threads where the shaft exits the inserter body.The inner shaft component is manufactured from 420 stainless steel and is not intended to be implanted.It is possible that the threaded connection seized due to impaction or rotation forces, contributing to the break when attempting to unthread the instrument from the implant.The exact cause of the reported issue could not be determined.
Event or Problem Description
The tip of the lateral inserter broke off in the implant during insertion.The surgeon did not remove the broken tip as it was flush with the implant and it remains in the patient.

• Brand Name: RISE-L
• Common Device Name: LATERAL INSERTER
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18826454
• Report Number: 3004142400-2018-00046
• Device Sequence Number: 3076054
• Product Code: LXH
• UDI-Device Identifier: 00889095058468
• UDI-Public: 00889095058468
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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: 693.601
• Device Lot Number: HAR353HBR-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown