MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP,

Model Number 1119.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2023

Event Type  malfunction  

Event Description

It was reported that a creo threaded locking cap is loose post operatively.

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.The imaging provided shows that the locking cap has backed out of the screw head.Additional information provided that the locking cap loosening occurred following a revision to extend the construct to the adjacent segment.No determinations could be made as to the cause of the reported issue.

Manufacturer Narrative

Four creo threaded locking caps and one creo threaded amp 5.0 x 55mm were returned for evaluation.Initial observation shows each one of the creo threaded locking caps with minor signs of thread deformation and showed edge loading marks due to contact with the rod when being tightened.Since the locking caps cannot be directly correlated to a specific screw, no determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a revision surgery was performed for (4) creo threaded locking caps that were loose post operatively.

• Brand Name: CREO
• Type of Device: CREO THREADED 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: 14657775
• MDR Text Key: 301272171
• Report Number: 3004142400-2022-00095
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0010
• Device Lot Number: BAY592RD/BAX683RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2021
• 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 Sex: Female