MAUDE Adverse Event Report: GLOBUS MEDICAL GLOBUS; GLOBUS CREO POLY SCREWS

Catalog Number 5119.065

Device Problem Fracture (1260)

Patient Problems Pocket Erosion (2013); Intraoperative Pain (2662)

Event Date 12/06/2023

Event Type  Injury  

Event Description

The patient underwent surgery on (b)(6) 2023 due to pain and broken screws from a prior back surgery.The patient had the following diagnoses postoperatively: localized pain over prominent right posterior iliac hardware with skin induration, at caudal end of right l3 to pelvis rods.Broken right lumbar screw rod connectors at the right ilium for both sides on the right side.Disconnected screw collar on right cranial iliac screws.Disengaged both set screws on the right rod-to-rod connector.Seroma around caudal end of right rods.No pus, inflammation or granulation to suggest infection.The patient was hospitalized following the procedure from (b)(6) 2023.

• Brand Name: GLOBUS
• Type of Device: GLOBUS CREO POLY SCREWS
• Manufacturer (Section D): GLOBUS MEDICAL; 2560 general armistead ave; audubon PA 19403
• MDR Report Key: 18408773
• MDR Text Key: 331582089
• Report Number: 18408773
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5119.065
• Device Lot Number: LOG1438293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBUS CLAMP SPNL T1 W REVERE 5.5-5.5MM LF NS-(B)(6) 2019-(B)(6) 2023; GLOBUS ROD CREO HEX END 5.5 X 300MM LOG 1438293-(B)(6) 2019-(B)(6) 2023; GLOBUS SCREW BN CREO 8.5 X 120MM LF NS PA- (B)(6) 2019-(B)(6) 2023
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White