MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VOYAGER FENESTRATED SCREWS; DISPENSER, CEMENT

Model Number 6550202

Device Problem Leak/Splash (1354)

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

Event Date 05/09/2022

Event Type  malfunction  

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.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for unknown indication.It was reported that a solera screw should be cemented with the help of the open delivery guide (6550039) and the fns tip (6550202).After placement, the polyaxiality appeared to be eliminated.However, during cementing, the cement leaked out at the tulip.The adapter was removed and cementing was successfully completed with another adapter.2022-may-19 (rep): additional information received from manufacturer representative that adapter was inserted properly, the polyaxiality was eliminated by the insertion, there was no indication that the adapter was not placed correctly.There was no damage or the like on the adapter or the screw.Despite professional handling, the cement leaked out.The patient was not harmed in any way, the application of the cement was immediately interrupted and completed with another model.There was no delay as facility had everything prepared in case it didn't work out.

• Brand Name: VOYAGER FENESTRATED SCREWS
• 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: 14595541
• MDR Text Key: 293656054
• Report Number: 1030489-2022-00519
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00763000211035
• UDI-Public: 00763000211035
• 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: Other
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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: KH19L828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2022
• Date Device Manufactured: 07/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female