MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 6.5X40MM POLYAXIAL SCREW

Model Number 5119.1642

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not able to be returned for evaluation as it was retained by the hospital.The s1 screws were replaced with a larger size, and the left l5 screw was replaced due to difficulty placing the new rod.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done to replace a screw which had loosened post-operatively causing adverse effects to the patient.

• Brand Name: CREO
• Type of Device: CREO THREADED 6.5X40MM POLYAXIAL SCREW
• 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: 10869274
• MDR Text Key: 226101116
• Report Number: 3004142400-2020-00157
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095104127
• UDI-Public: 00889095104127
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.1642
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/19/2020
• 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: 88 YR