MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; CREO THREADED LOCKING CAP

Model Number 1119.0010

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.The imaging provided shows the separation of locking caps from the screw head on the left side at l3 and l5 and on the right side at l5.In addition, the rod on the left side of the construct had bilateral screws at l3 and l5 of a l3-l5 fusion.It is possible that excessive cantilever force was placed on the l3 and l5 screws due to a lack of fixation point at l4 where no screws were placed; however, an exact cause to the reported issue could not be determined.

Event Description

It was reported that a revision surgery was done to replace (3) creo mis locking caps that had loosened with subsequent post operative rod migration.This event occurred in austria.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO THREADED LOCKING CAP
• 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: 15083226
• MDR Text Key: 303844572
• Report Number: 3004142400-2022-00117
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1119.0010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White