MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE-L; RISE-L/ELSA INSERTER, GPS

Model Number	6143.1337
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial observation shows that the threaded tip of the inserter has sheared off.The inserter tip is threaded into the implant and should not pose a risk for migration.An exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that the threaded tip of a rise-l inserter was left in the patient after it broke during surgery.

• Brand Name: RISE-L
• Common Device Name: RISE-L/ELSA INSERTER, GPS
• 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 ; 6109301822
• MDR Report Key: 13004091
• Report Number: 3004142400-2021-00234
• Device Sequence Number: 13839502
• Product Code: OLO
• UDI-Device Identifier: 00193982143091
• UDI-Public: 00193982143091
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D353991
• 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): 12/07/2021

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: 6143.1337
• Device Lot Number: ENY187AC*F
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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