MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO THREADED 7.5X55MM POLYAXIAL SCREW, COCR HEAD, TI SHANK

Model Number 5146.1757; 1210.1253

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

It was reported that there was a revision surgery to replace a creo threaded screw that was loose with subsequent hedron spacer backing post-operatively.

Manufacturer Narrative

The device was not available for evaluation.The imaging provided shows possibly a few millimeters of the rod protruding out of the screw head, ensuring that the rod was fully captured by the screw head.Images provided after the device migration shows that the rod slipped out of the screw head at s1 level.Imaging also shows the hedron p spacer appears to have migrated posteriorly and is sitting outside the vertebral bodies.It's possible that improper placement, improper implant sizing, or improper implant height may have contributed to the migration; however, an exact cause of the reported issue could not be determined.

Manufacturer Narrative

A single "creo threaded 7.5x55mm polyaxial screw, cocr head, ti shank" and a single "hedron p spacer" were returned for evaluation.Initial observation of the screw shows deformation/damage on the retaining feature of the screw head that mates with most instruments.This observed damage may have been caused during removal of the implant as it is consistent with damage caused from a mating instrument.Initial observation of the spacer showed no defects, however, superficial damage is observed near the posterior of the implant, possibly from retrieval of the implant.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that there was a revision surgery to replace a creo threaded screw that was loose with subsequent hedron spacer backing post-operatively.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO THREADED 7.5X55MM POLYAXIAL SCREW, COCR HEAD, TI SHANK
• 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 ; 6109301800
• MDR Report Key: 15579074
• MDR Text Key: 307189426
• Report Number: 3004142400-2022-00149
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889095130287
• UDI-Public: 00889095130287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143633
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5146.1757; 1210.1253
• Device Lot Number: BAX359BB; BAW740AB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• 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