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

Model Number	693.601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the tip of the lateral inserter was broken and left in the cage post operatively.
Additional Manufacturer Narrative
The device was available for evaluation.One lateral inserter was returned due to intraoperative fracture of the instrument tip.The reported event occurred when treating l2/l3 during an l1-3 llif (dos: (b)(6) 2024), using two elsa expandable spacers.According to the event reporting, a 55mm elsa spacer was successfully inserted using the lateral inserter and expanded in the l1/2 disc space.The surgeon proceeded to load a 50mm elsa spacer onto the lateral inserter and insert the implant into the l2/3 disc space.While malleting the implant into the disc space, the inserter came loose from the implant.It was later determined that the threaded rod that engages with the threaded hole on the implant had fractured and stuck in the implant.The surgeon attempted to remove the instrument tip from the implant as well as remove the implant from the disc space but was unsuccessful.The surgeon then proceeded to expand the spacer in situ and secure the implant with lateral bone screws, with the instrument tip left inside the implant.From the provided postoperative imaging and reporting, the fractured tip appears to be flush with the nose of the implant, and no metal is protruding from the profile of the spacer.Examination of the instrument revealed rust on the newly exposed metal of the fractured rod, however it could not be established if the rust was present prior to the instrument fracture.No other instrument defects were identified.No determinations could be made as to the cause of the reported issue.

• 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: 20354127
• Report Number: 3004142400-2024-00211
• Device Sequence Number: 3351686
• 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
• Device Implanted Year: 2024
• 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): 10/02/2024

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: ENY336BF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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: Male