MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS 5.5MM CURVED ROD, COBALT CHROME, 75MM LENGTH

Model Number 7134.7075

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device or any imaging was available 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 to remove and replace a rod which had migrated post-operatively.

• Brand Name: CREO
• Type of Device: CREO MIS 5.5MM CURVED ROD, COBALT CHROME, 75MM LENGTH
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11096624
• MDR Text Key: 225349792
• Report Number: 3004142400-2020-00183
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095200461
• UDI-Public: 00889095200461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124058
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7134.7075
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2020
• 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: 29 YR
• Patient Weight: 120