MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO MIS; CREO MIS LOCKING CAP

Model Number 1134.0010

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

The devices were not available for evaluation as they remain in the patient.The imaging provided at the final time point revealed rod motion relative to the l5 screws bilaterally only.This may indicate the occurrence of rod slippage.Each interconnection at the l3 and l4 screws appears to remain fixed.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that creo mis locking caps (2) have migrated 8 months post operatively, with subsequent rod migration.This event occurred in(b)(6).

Manufacturer Narrative

The devices were not available for evaluation as they remain in the patient.The imaging provided at the final time point revealed rod motion relative to the l5 screws bilaterally only.This may indicate the occurrence of rod slippage.Each interconnection at the l3 and l4 screws appears to remain fixed.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that creo mis locking caps (2) have migrated 8 months post operatively, with subsequent rod migration.This event occurred in (b)(6).

Manufacturer Narrative

Two locking caps along with related hardware were returned for evaluation.Imaging provided shows rod motion relative to the l5 screws bilaterally only.This may indicate the occurrence of rod slippage.Each interconnection at the l3 and l4 screws appears to remain fixed.There is no clear visual indicator that any locking cap has fully dislodged from a screw head, however observations of wear markings on the bottom of each locking cap indicate loading likely occurred primarily around the cap outer edge.This would indicate that those screw heads had not normalized to the rod which may have contributed to loosening.However the exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was completed due to creo mis locking caps (2) that have migrated 8 months post operatively, with subsequent rod migration.This event occurred in japan.

• Brand Name: CREO MIS
• Type of Device: CREO MIS 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: 13027701
• MDR Text Key: 286060031
• Report Number: 3004142400-2021-00223
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1134.0010
• Device Lot Number: BAX529GB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Asian