MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO 4.75, 6.5 X 30MM HA COATED MONOAXIAL SCREW

Model Number 5067.0631S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Spinal Cord Injury (2432)

Event Date 10/30/2018

Event Type  Injury  

Event Description

The patient was treated using anterior tethering for adolescent idiopathic scoliosis in turkey two months prior to revision.The patient is a 15 year old uk citizen, taken abroad for surgery by parents.Presented to our unit with two litre haemothorax.At review two screws adjacent to descending aorta, two screws eroded through the diaphragm and two screws compressing renal artery and adrenal gland.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The devices were not returned for evaluation and no radiographic imaging was available for review.A total of 8 thoracic screws and 9 lumbar screws were placed.It was reported that the lower two screws in the thoracic construct were left proud and had eroded the diaphragm.This suggests the screws were not fully seated against the vertebral bodies.Two screws were also found to be compressing on the renal artery and adrenal gland.The most likely cause of the patient's condition is due to implant selection and insertion technique.

• Brand Name: CREO
• Type of Device: CREO 4.75, 6.5 X 30MM HA COATED MONOAXIAL SCREW
• 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: 18831759
• MDR Text Key: 336825177
• Report Number: 3004142400-2018-00058
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00889095339635
• UDI-Public: 00889095339635
• 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

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5067.0631S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• 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: 15 YR
• Patient Sex: Female
• Patient Race: White