MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION; CREO THREADED POLYAXIAL SCREW

Model Number 1210.1293

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2022

Event Type  malfunction  

Event Description

It was reported that there was a revision surgery to replace (2) creo screws loose at s1 bilaterally with subsequent hedron spacer backing out at l5-s1 post-operatively.

Manufacturer Narrative

The device was not available for evaluation.The imaging provided shows the hedron p spacer appearing to have migrated posteriorly and sitting outside the vertebral bodies.Additional information provided that the screw was attached to the rod but the screw itself had back out from the pedicle.It's possible that improper placement, implant sizing or implant height may have contributed to the migration; however, an exact cause of the reported issue could not be determined.

Event Description

It was reported that there was a revision surgery to replace (2) creo screws loose at s1 bilaterally with subsequent hedron spacer backing out at l5-s1 post-operatively.

Manufacturer Narrative

The creo screws could not be provided for evaluation.The hedron implant was returned for evaluation; initial observation shows no defects of the device.No determinations could be made as to the cause of the reported issue.The following sections have been updated:.

• Brand Name: CREO STABILIZATION
• Type of Device: CREO THREADED POLYAXIAL SCREW
• 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: 15579075
• MDR Text Key: 306650241
• Report Number: 3004142400-2022-00145
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1210.1293
• Device Lot Number: BAW719JB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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