MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SUSTAIN; SUSTAIN® RADIOLUCENT TPS SPACER, OBLIQUE, SMALL

Model Number	304.082CS
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Sustain spacers implanted at l4-l5 and l5-s1 migrated out of the disc space.No immediate post-op films were available for comparison.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The returned implants were evaluated, portions of the tallest teeth on both spacers appear to have been sheared off, likely due to explantation.Measurements were taken of both spacers and they were found to be within drawing specifications.It cannot be determined what caused the spacers to back out.During the revision surgery the rod and screws were removed from the left side in order to access the sustain spacers, they were not replaced.The following sections have been changed for this supplemental report: b4; e3; g6; g7; h2; h5; h6; h10.

• Brand Name: SUSTAIN
• Common Device Name: SUSTAIN® RADIOLUCENT TPS SPACER, OBLIQUE, SMALL
• 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: 18825120
• Report Number: 3004142400-2018-00001
• Device Sequence Number: 20780005
• Product Code: MAX
• UDI-Device Identifier: 00889095235067
• UDI-Public: 00889095235067
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• 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): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 304.082CS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2014
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White