MAUDE Adverse Event Report: ORMCO CORPORATION VECTORTAS; VECTORTAS MINI SCREW

Catalog Number 601-0020

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

It was alleged that the head of vectortas broke off in the patient's mouth.It was confirmed that no injury was associated with this incident.To date the patient is doing fine.

Event Description

It was alleged that the head of vectortas broke off in the patient's mouth.

• Brand Name: VECTORTAS
• Type of Device: VECTORTAS MINI SCREW
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill ave.; glendora 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 6760236
• MDR Text Key: 81902500
• Report Number: 2016150-2017-00004
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 601-0020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR