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

Catalog Number	601-0021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 2016150-2023-00008
• Device Sequence Number: 6420724
• Product Code: DZL
• UDI-Device Identifier: 10889989000082
• UDI-Public: 10889989000082
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown