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

Model Number 5119.6640

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Neither the devices nor any imaging was available for evaluation.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that 2 cases of revision surgeries occurred due to preassembled creo threaded screw heads failing post operatively.These event took place in (b)(6).

Manufacturer Narrative

Two implants were returned for evaluation with the screw head, saddle, clamp and screw shank dissociated from the assembly.One of the screw heads was also found to be splayed with respect to the rod slot.It is possible that the rod slot splayed during the removal process.However, the exact cause of the reported issue could not be determined.The following sections were updated: b4, d2, d4, d9, e1, g1, g4, g6, h2, h3, h4, h6, and h10.

Event Description

It was reported that 2 cases of revision surgeries occurred due to preassembled creo threaded screw heads failing post operatively.These event took place in belgium.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO THREADED 6.5X40MM REDUCTION SCREW
• 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: 12806504
• MDR Text Key: 287526672
• Report Number: 3004142400-2021-00229
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D201515
• 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,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5119.6640
• Device Lot Number: JNW003MJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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