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

Model Number 1119.0010

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The locking cap and mating screw were returned for evaluation.The bottom surface of the locking cap was polished around the outside and a crack had partially propagated from the thread start across the minor diameter.Marks and polished surfaces from rod contact and rubbing were found on the screw on both sides of the rod slot and on one side of the saddle.The observed wear marks are consistent with rubbing between the rod and screw head after the locking cap had loosened.Witness marks typically observed during proper tightening could not be verified.The fracture across the thread start may have been caused by contact with the rod and fatigue loading after the locking cap had loosened, or by damage to the thread start during implantation.The observed pseudoarthrosis and two years of patient loading indicate that the implants may have been subjected to fatigue loading in excess of the anticipated life of the implant however, the exact cause of the reported issue could not be determined.

Event Description

It was reported that a creo locking cap backed out of the screw head approximately two years post-operative.

• Brand Name: CREO
• 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: 18825810
• MDR Text Key: 336874376
• Report Number: 3004142400-2020-00054
• 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: 03/04/2024

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: 1119.0010
• Device Lot Number: BAU220MD
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Disability; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Race: Asian