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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No parts were available for evaluation as they were discarded by the hospital.Additional information provided revealed that during the revision surgery to address the slipped rod, it was discovered that the locking cap at the slipped level was loose.When the surgeon removed the locking cap and attempted to return the rod to the left s1 screw and re-tighten the screw, they were unable to successfully tighten the screw to the rod.This was observed to be caused by the rod which inadequately contoured to properly be seated to the rod slot.After this was discovered, the surgeon removed both left and right rods, s1 screws and the corresponding locking caps.Following the removal of these implants, the surgeon extended the construct to s2, replacing the s1 and s2 screws with s2ai screws and new locking caps.It is possible that the polyaxial screw was position at its maximum angle and was incompatible with the contour of the rod to allow the rod to fully be seated in the rod slot and thus not allowing the screw to be fully locked onto the rod; however, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a creo threaded rod has slipped out of l2 to sacrum 2 weeks post operatively.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO 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 ; 6109301822
• MDR Report Key: 12790829
• MDR Text Key: 287260600
• Report Number: 3004142400-2021-00216
• Device Sequence Number: 1
• Product Code: MNH
• 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
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: No
• 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