MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 5.5 LOCKING CAP NS

Model Number 1119.0050

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the suspect device shows significant rod impressions on the base of the set screws which is consistent with excessive downward pressure to engage the locking cap within the screw head.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was completed due to creo locking caps loosening post-operatively.

• Brand Name: CREO
• Type of Device: CREO 5.5 LOCKING CAP NS
• 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: 12086019
• MDR Text Key: 261692013
• Report Number: 3004142400-2021-00116
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095733082
• UDI-Public: 00889095733082
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D347174
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0050
• Device Lot Number: BAX090MC/BAX243XC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 06/02/2021
• 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