MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED LOCKING CAP

Model Number 1119.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.Imaging provided shows the locking cap at l2 to be completely dissociated from the screw.Additional information provided shares that the locking cap at t12 had partially dissociated from the screw.As the implants were not returned post revision surgery, the parts cannot be properly evaluated and an exact cause of the reported issue could not be determined.

Event Description

It was reported there is a revision surgery is needed to replace screws that have loosened 5 years post operatively.

Manufacturer Narrative

A visual inspection of the locking caps revealed the thread major and the thread minor are within specification.Lateral x-rays show the locking cap at l2 to be completely dissociated from the screw.However an exact cause to the reported issue could not be determined.

Event Description

It was reported there is a revision surgery is needed to replace screws that have loosened 5 years post operatively.

• Brand Name: CREO
• Type of Device: CREO THREADED LOCKING CAP
• 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 ; 6109301822
• MDR Report Key: 12855923
• MDR Text Key: 286116640
• Report Number: 3004142400-2021-00219
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Date Manufacturer Received: 10/25/2021
• 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: 20 YR
• Patient Sex: Male
• Patient Race: Black Or African American