MAUDE Adverse Event Report: ORMCO VECTORTAS 8MM MIN-SCREW - 6 PK

Catalog Number 601-0021

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

It was reported a malfunction in vectortas mini screw product.Screw was broken in patient's teeth root, and the broken part was removed with the help of a surgeon.The patient received two stitches.Product was being used on the patient when it broke.Product was not swallowed and the portion of the product was retrieved.There were no any other product used during the same time.Patient did not go the hospital or seek medical attention with a doctor.Patient was referral to a surgeon.There was no follow-up visit required or medical prescription.

• Brand Name: VECTORTAS 8MM MIN-SCREW - 6 PK
• Type of Device: VECTORTAS 8MM MIN-SCREW - 6 PK
• Manufacturer (Section D): ORMCO; 1937 west mission blvd; pomona CA 91766
• Manufacturer (Section G): ORMCO; 1937 west mission blvd; pomona CA 91766
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821 ; 7148174396
• MDR Report Key: 18159842
• MDR Text Key: 328401969
• Report Number: 2016150-2023-00008
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10889989000082
• UDI-Public: 10889989000082
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/08/2023

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 Catalogue Number: 601-0021
• Device Lot Number: 9348771N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention