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

Model Number	1124.1111
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was an issue removing an altera spacer during surgery, and it was left in the patient post operatively.This event occurred in japan.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.The implant was not able to be expanded, and then it was disengaged from the inserter assembly.The implant expansion driver was returned for evaluation.The driver was found to fail the functional gage for implant drive nut engagement, however it was found to engage as intended with multiple different implants.The cause of the functional failure was deemed to be due to wear in the driver tip, which may have been caused from normal use or implant expansion while the driver is only partially engaged with the implant expansion nut.If the inserter assembly is subject to any pulling force during expansion, the implant can be disengaged from the driver, causing partial engagement and therefore wear to the driver.It is also possible to become fully disengaged from the implant when using the inserter in this manner, which could potentially explain the failure to expand the implant.No determinations could be made as to the cause of the reported issue.

• 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: 18837330
• Report Number: 3004142400-2023-00182
• Device Sequence Number: 7486381
• 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): 03/02/2024

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: 1124.1111
• Device Lot Number: BAA346CG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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: Male
• Patient Race: Asian