MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SABLE EXPANDABLE INTERBODY FUSION DEVICE; SABLE SPACER, 10X22, 9-15MM, 22°

Model Number	1172.2033S
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a revision surgery to replace a sable spacer at l5-s1 that had migrated posteriorly into the canal post-operatively.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows the implant is disassembled.This disassembly likely occurred as a result of over-collapsing the implant when retrieving the implant during the revision surgery, as there is no torque-limiting protection for collapsing the implant.The imaging provided shows the l5-s1 sable implant sitting posterior, partially outside the vertebral body.An immediate post-operative image shows the implant in position and expanded.It is hard to tell if any expansion height was lost in the post-migration imaging, as artifacts are obscuring the implant.Possible contributing factors to the failure include improper placement, improper implant sizing, or improper implant height; however, an exact cause to the reported issue could not be determined.

• Brand Name: SABLE EXPANDABLE INTERBODY FUSION DEVICE
• Common Device Name: SABLE SPACER, 10X22, 9-15MM, 22°
• 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: 14521378
• Report Number: 3004142400-2022-00077
• Device Sequence Number: 14921883
• Product Code: MAX
• UDI-Device Identifier: 00889095965926
• UDI-Public: 00889095965926
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 05/17/2022

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: 1172.2033S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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