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

Model Number	1124.1111
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the spacer was not able to expand, but was left in the patient post operatively.This event occurred in japan. .
Additional Manufacturer Narrative
The device was not available for evaluation.The expansion driver was returned under and was able to successfully expand implants during evaluation.It is possible that the expansion driver was not properly engaged with the expansion feature of the implant leading to a lack of expansion, however because the implant was not returned for evaluationno determintions could be made as to the cause of the reported issue.

• Brand Name: ALTERA
• Common Device Name: ALTERA SPACER, 10X31, 8-12MM, 8°
• 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: 19104493
• Report Number: 3004142400-2024-00066
• Device Sequence Number: 18068705
• 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: 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): 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: 1124.1111
• Device Lot Number: BAB854SG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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
• Patient Race: Asian