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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a revision was done for loose locking caps post-operatively.This event occurred in (b)(6).

Manufacturer Narrative

Neither the device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that a revision was done for loose locking caps post-operatively.This event occurred in belgium.

• Brand Name: CREO STABILIZATION SYSTEM
• Type of Device: CREO 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 ; 6109301822
• MDR Report Key: 12715372
• MDR Text Key: 280877078
• Report Number: 3004142400-2021-00215
• Device Sequence Number: 1
• Product Code: MNH
• 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: 11/09/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 11/19/2021
• 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 Age: 95 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White