MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON® FENESTRATED SCREW SET; DISPENSER, CEMENT

Model Number 6550202

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient implanted with cement in an augmentation procedure.It was reported that the cement leaked into screw tulip due to cementation with voyager screws.Screws have been used with augmentation procedure but the cement leaked out between screw crone and voyager disposable.There were no patient symptoms or complications associated with this event.There was a delay of 30 minutes in the surgery.No further complications were reported/ anticipated.

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® FENESTRATED SCREW SET
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13469666
• MDR Text Key: 285172387
• Report Number: 1030489-2022-00102
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 20763000211039
• UDI-Public: 20763000211039
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2022

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: 6550202
• Device Catalogue Number: 6550202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 02/07/2022
• 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