MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO AMP 5.5 CLOSED POLYAXIAL TULIP

Model Number 1119.0150

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.Imaging provided show dissociation of the screw head from the rod.However, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a creo screw head has loosened with subsequent rod migration 6 weeks post operatively.

• Brand Name: CREO
• Type of Device: CREO AMP 5.5 CLOSED POLYAXIAL TULIP
• 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: 13445077
• MDR Text Key: 287526254
• Report Number: 3004142400-2022-00010
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059694
• UDI-Public: 00889095059694
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2022
• 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