MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XPAND; XPAND CORPECTOMY SPACER, SMALL, 12X14, 3.5/3.5°, 42-57MM

Model Number	116.111
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Spinal Column Injury (2081)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed to replace an xpand corpectomy spacer that was found collapsed post operatively.This event occurred in spain.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Neither the device or any images could be provided for evaluation.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The device was available for evaluation.The implant was received in its most contracted state.The locking set screw was presumed to be in the unlocked state because the implant would expand and contract freely upon rotation of the bevel gear.After microscope images of the implant were collected, the implant was fully expanded by rotating the bevel gear.A wear pattern across the peaks of the threads, in-line with the locking set screw, were observed as shown in the images.This wear pattern indicates that the locking set screw was engaged at some point.The locking capabilities of the set screw could not be properly evaluated because the hex fastening feature on the locking set screw was stripped as show in the images.The hex driver could not engage the set screw enough to tighten or loosen the fastener.It is not known when the hex feature was stripped, but if it occurred during the locking step, then the locking set screw would not have engaged fully with the threads (i.E.The implant would've been partially locked).This could explain why the implant collapsed, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was needed to replace an xpand corpectomy spacer that was found collapsed post operatively.This event occurred in spain.

• Brand Name: XPAND
• Common Device Name: XPAND CORPECTOMY SPACER, SMALL, 12X14, 3.5/3.5°, 42-57MM
• 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: 18811106
• Report Number: 3004142400-2023-00204
• Device Sequence Number: 3338818
• Product Code: MQP
• UDI-Device Identifier: 00849044022551
• UDI-Public: 00849044022551
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 116.111
• Device Lot Number: BGA063DK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown