MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5 LOCKING CAP

Model Number 1119.0000

Device Problem Device Slipped (1584)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a revision surgery was done for 2 s1 locking caps that allowed for the rod to slip post-operatively.

Manufacturer Narrative

The device was available for evaluation.The observed failure is consistent with error in user technique.The instability of the construct due to the rod slippage could have allowed for the rise cage to migrate out of the disc space.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done for 2 s1 locking caps that allowed for the rod to slip post-operatively.

• Brand Name: CREO
• Type of Device: CREO 5.5 LOCKING CAP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10879452
• MDR Text Key: 226100960
• Report Number: 3004142400-2020-00159
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059489
• UDI-Public: 00889095059489
• Combination Product (y/n): N
• PMA/PMN Number: K124058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0000
• Device Lot Number: BAX155LD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other