MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 50MM LENGTH

Model Number 1134.7050

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned devices showed the screw heads to display extreme amounts of wear on exterior surfaces.The location of the damage observed indicates that the wear is very likely the result of the implant removal.The wear patterns on the rods show evidence of sliding; however, it cannot be determined if this occurred while implanted or during removal.The locking caps show areas of stripped anodizing, and the wear pattern on the bottom surface is inconsistent.The ring pattern around the outer diameter may indicate tightening of the locking cap while the screw head is not normalized to the rod.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done for two creo mis rods that were loose post-operatively.

• Brand Name: CREO
• Type of Device: CREO MIS 5.5MM CURVED ROD, TITANIUM ALLOY, 50MM 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: 11952106
• MDR Text Key: 258388895
• Report Number: 3004142400-2021-00108
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095072181
• UDI-Public: 00889095072181
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2021

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: 1134.7050
• Device Lot Number: JNW238JC/JNW345RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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