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

Model Number 1192.0020

Device Problem Human-Device Interface Problem (2949)

Patient Problem Spinal Column Injury (2081)

Event Type  malfunction  

Event Description

It was reported that creo fenestrated locking caps that were found loosened post operatively with subsequent rod migration.This event occurred in germany.

Manufacturer Narrative

The part was available for evaluation.It was reported that creo fenestrated locking caps were found disassociated from the screw head via post-operative imaging.The x-rays were taken after the patient had complained of pain.Imaging confirmed that creo mis fenestrated screws were placed at l1 & l3.The right locking caps at l1 have loosened and the right rod has slipped.It could not be determined if the locking caps on the left side at l1&l3 were loose based on the returned images.There was no information on post operative conditions and whether there was any trauma or excessive forces placed on the construct.Because surgical and post-op conditions could not be replicated, no determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Type of Device: CREO FENESTRATED, 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: 18617855
• MDR Text Key: 334500859
• Report Number: 3004142400-2024-00017
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172269
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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?: No
• Date Manufacturer Received: 01/09/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 84 KG