MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 5.5MM STRAIGHT ROD, TITANIUM ALLOY, 125MM LENGTH

Model Number 1119.5125

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.Imaging provided confirmed the rod slipping out of the screw head on the left side.The slippage is consistent with increased instability in the construct following the previously reported screw loosening and screw head pop-off.

Event Description

It was reported by a representative from japan that a revision surgery was done for a rod that deviated post-operatively.

Event Description

It was reported by a representative from japan that a revision surgery was done for a rod that deviated post-operatively.

Manufacturer Narrative

Inspection of the subject device found no major defects or damage to the rod.The rod had been cut on one end, and there was no curvature placed in the rod.The slippage is consistent with increased instability in the construct following the previously reported screw loosening and screw head pop-off; however, the exact cause of the reported issue could not be determined.

• Brand Name: CREO
• Type of Device: 5.5MM STRAIGHT ROD, TITANIUM ALLOY, 125MM LENGTH
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11689137
• MDR Text Key: 257692812
• Report Number: 3004142400-2021-00053
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095064339
• UDI-Public: 00889095064339
• Combination Product (y/n): N
• PMA/PMN Number: K124058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.5125
• Device Lot Number: CLV618BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other