MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RISE EXPANDABLE SPACER; INSERTER FORK, 12MM

Model Number	693.013
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows the tip of the instrument to be splayed.Additional information provided that the surgeon had difficulty disengaging the fork from the implant.If there was excessive force when attempting to disengage, it's possible for the fork to be damaged in the manner exhibited; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that during a procedure an inserter fork met resistance and then a dural tear was observed and fixed intraoperatively.

• Brand Name: RISE EXPANDABLE SPACER
• Common Device Name: INSERTER FORK, 12MM
• 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: 15736991
• Report Number: 3004142400-2022-00155
• Device Sequence Number: 6322086
• Product Code: LXH
• UDI-Device Identifier: 00889095058208
• UDI-Public: 00889095058208
• 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): 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 693.013
• Device Lot Number: BJV009TC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2018
• 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: 80 YR
• Patient Sex: Female
• Patient Race: White