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

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported after patient experienced adverse effects, the left l4 screw had breached laterally 2 days post operatively.

Manufacturer Narrative

Investigation revealed that there was no system malfunction.It was determined that the starting point of the l4-l screw was planned in a high-skive area.Additional pedicle preparation would have been needed to help place the screw due to risk of skiving upon entrance.Existing safety mitigations include the screw plan being overlaid on patient anatomy using the intra-operative ct scan.Additionally, the software will alert the user if excessive deflection forces are detected on the load cell during bone work.The cause of the reported issue was traced to user technique.

• Brand Name: CREO
• Type of Device: CREO 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: 12971307
• MDR Text Key: 283602072
• Report Number: 3004142400-2021-00227
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White