MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ALTERA; ALTERA SPACER, 10X31, 8-12MM, 8 DEG

Model Number	1124.1111
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.Images of the inserter and implant assembly were provided.It can be seen that the drive nut on the implant is not engaged with the driver shaft of the inserter assembly.It is possible that the drive features were not properly aligned before threading the implant onto the inserter, causing implant expansion to not be possible.However, since implant was not returned for evaluation no determinations could be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that an altera spacer was left in the patient post operatively after it did not expand.This event occurred in japan. .

• Brand Name: ALTERA
• Common Device Name: ALTERA SPACER, 10X31, 8-12MM, 8 DEG
• 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: 18811048
• Report Number: 3004142400-2023-00203
• Device Sequence Number: 11594450
• Product Code: MAX
• UDI-Device Identifier: 00889095069679
• UDI-Public: 00889095069679
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 02/29/2024

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: 1124.1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Race: Asian