MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT

Model Number 6067.0050

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Neither the part nor any imaging was available regarding the spacer.Additional information provided that the tip of the driver fractured during an attempt to remove the locking cap, meaning that the tip yielded and fractured in a counter-clockwise direction.This is consistent with the driver being subject to excessive force; however, the exact cause of the reported issue could not be determined.

Event Description

It was reported by a representative from japan that a revision surgery was done to remove a spacer due to patient pain.During the surgery, the driver tip broke and remains in the patient.

Event Description

It was reported by a representative from japan that a revision surgery was done to remove a spacer due to patient pain.During the surgery, the driver tip broke and remains in the patient.

Manufacturer Narrative

Neither the part nor any imaging was available regarding the spacer.Additional information provided that the tip of the driver fractured during an attempt to remove the locking cap, meaning that the tip yielded and fractured in a counter-clockwise direction.This is consistent with the driver being subject to excessive force; however, the exact cause of the reported issue could not be determined.

• Brand Name: CREO
• Type of Device: DRIVER SHAFT, 1/4" QUICK-CONNECT, SHORT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11689131
• MDR Text Key: 248494993
• Report Number: 3004142400-2021-00070
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• Combination Product (y/n): N
• PMA/PMN Number: D154976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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: 6067.0050
• Device Lot Number: ADV052AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR