MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS STABILIZATION SYSTEM; CREO MIS LOCKING CAP

Model Number 1134.0010

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Initial observation shows the locking cap having an indentation at the center of the face that contacts the rod.The imaging provided shows the engagement between the rod and the locking cap to be around the region of the rod where it's conical end taper starts.The length of the rod seems to be sufficient, but the rod overhang beyond the screw heads was observed to be much longer at the rod attachment end compared to its conical tip end.It's possible that the superimposing images of the left and right side rods may have made it difficult to determine the rod overhang using the lateral x-ray.At the observed position of the rod, the start of the taper may lay around the center of the locking cap, resulting in non-uniform forces exerted by the rod on the locking cap, thereby contributing towards loosening the locking cap.The indentation observed at the center of the flat face of the locking cap is further indictive of this possibility.Although the images show the rod not fully seated into the screw head prior to the second surgery, it is not certain whether the image was taken post-operatively immediately after rod placement or later after reporting the locking cap migration.An exact cause of the reported issue could not be determined.

Event Description

It was reported there was a revision surgery due to a creo mis locking cap that was loose post operatively.

• Brand Name: CREO MIS STABILIZATION SYSTEM
• Type of Device: CREO MIS LOCKING CAP
• 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: 15421096
• MDR Text Key: 300594246
• Report Number: 3004142400-2022-00136
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• 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: 08/31/2022

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
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAA030WC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Race: White