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	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The instrument is ur-1available for evaluation.It was stated that the surgeon attempted to remove the broken tip but was not able to move or rotate the piece.The broken tip is threaded securely into the implan'i and is not likely to migrate post-operatively.The inner shaft component is manufactured from 420 stainless steel and is not intended to be implanted.No determination could be made as to the cause of the breakage.
Event or Problem Description
The tip of the lateral inserter broke off in the rise-l implant.The surgeon was unable to remove the broken tip 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: 18825777
• Report Number: 3004142400-2018-00035
• Device Sequence Number: 12692929
• 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): 03/03/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 69 YR
• Patient Sex: Male