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

Model Number 1119.0010

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device could not be returned for evaluation as it was discarded by the hospital.Imaging provided shows that the right side of the original construct, l3-s2, with each of the five locking caps sitting proud.Additional information provided that the patient was implanted with creo threaded cocr preassembled implants with two 5.5mm tav rods.The surgeon pre-contoured the rods prior to placement and reduced the rods to the spine with a combination of the tower reducer, overhead reducer and reduction fork before final tightening each level with the prescribed 10 nm final tightening torque handle.The patient presented approximately one month post-operative with pain/discomfort which prompted the need for the revision surgery to correct the loosened caps.The patient was revised with new caps.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a revision sugary was needed to remove (20) creo threaded locking caps that were loose 1 month post operatively.

• 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: 15105002
• MDR Text Key: 304103965
• Report Number: 3004142400-2022-00112
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1119.0010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2022
• 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
• Patient Age: 46 YR
• Patient Sex: Male