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

Model Number 1192.0020

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

The devices were not available for evaluation as they remain in the patient.Imaging provided shows a displaced locking cap and fractured screw shank.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a locking cap popped off and a screw came loose and fractured post-operatively.

Manufacturer Narrative

Evaluation of the hardware received shows wear and markings consistent with normal use.Imaging provided shows a displaced locking cap and fractured screw shank.It was determined during the surgery that the patient had significant osteoporosis which may have been a contributing factor.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was completed due to a locking cap popping off, and a screw loosening and fracture post-operatively.

• Brand Name: CREO
• Type of Device: CREO FENESTRATED, MIS LOCKING CAP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11778759
• MDR Text Key: 251663558
• Report Number: 3004142400-2021-00084
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K172269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1192.0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other