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

Model Number 1134.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

The four locking caps, four screw heads, and two rods were returned for evaluation.Initial observation shows surface markings and deformation on the threads and bottom surface of the locking caps which is consistent with tightening onto a rod.The locking cap did not thread smoothly into one of the returned screw heads, which is expected from wear observed on the screw head threads.The imaging provided shows four loose locking caps.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a revision surgery was needed to remove (4) creo locking caps that were loose 8 months 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: 15960473
• MDR Text Key: 307682798
• Report Number: 3004142400-2022-00167
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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: BAX696LC/BAX706RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• 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: 59 YR
• Patient Sex: Male