MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SABLE; SABLE SPACER, 12X30, 6-12MM, 8°

Model Number 1172.4210S

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it has been retained by the hospital.Additional information provided that the surgeon had turned the expansion handle counterclockwise in attempt to contract the implant multiple times to reposition.This causes the implant to contract in height and could cause the disassociation from the front ramp.It appears the issue is due to misuse; however, the exact cause of the reported issue could not be determined.

Event Description

It was reported that the tip of a sable spacer was left inside the patient and could not be retrieved.

• Brand Name: SABLE
• Type of Device: SABLE SPACER, 12X30, 6-12MM, 8°
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11282826
• MDR Text Key: 231414918
• Report Number: 3004142400-2021-00019
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1172.4210S
• Device Lot Number: GBX726WC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR