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

Model Number 1134.0010

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the suspect device revealed regions of wear and abrasion to the surfaces, specifically on the bottom surface.It is possible the wear occurred during the removal process or while implanted.The locking caps appeared to function as expected and assemble nominally to the screw head.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done due to a locking cap which dislodged from the left l4 screw post-operatively.

• Brand Name: CREO
• Type of Device: CREO MIS LOCKING CAP
• 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: 11408098
• MDR Text Key: 246203706
• Report Number: 3004142400-2021-00037
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAX529GB/BAX298WB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2021
• 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
• Patient Age: 64 YR
• Patient Weight: 109