MAUDE Adverse Event Report: HANDPIECE HEADQUARTERS MAXIMA PRO 45 N/O FIXED END; HANDPIECE

Model Number MAXIMA PRO 45

Device Problems Detachment of Device or Device Component (2907); Inadequate Lubrication (4057)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

After patient has swallowed the surgical bur (541), patient went to promedica monroe regional hospital for medical treatment where an x-ray was taken at emergency center.No findings, and patient has since returned to dental office with no complaints.

Event Description

Patient swallowed surgical bur (541) during full mouth extraction surgery.

• Brand Name: MAXIMA PRO 45 N/O FIXED END
• Type of Device: HANDPIECE
• Manufacturer (Section D): HANDPIECE HEADQUARTERS; 620 s. placentia ave.; placentia CA 92870
• Manufacturer (Section G): HANDPIECE HEADQUARTERS; 620 s. placentia ave.; placentia CA 92870
• Manufacturer Contact: frederick wang ; 620 s. placentia ave.; placentia, CA 92870 ; 7145790175
• MDR Report Key: 15374400
• MDR Text Key: 299449108
• Report Number: 3007007357-2022-00011
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 45
• Device Catalogue Number: 112-6771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male