MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH INTEGO; UNIT, OPERATIVE DENTAL

Catalog Number 6427277

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that an intego operative unit adapter plate connecting the chair with the base broke; no injury resulted.

• Brand Name: INTEGO
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 10951513
• MDR Text Key: 220429214
• Report Number: 9614977-2020-00049
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6427277
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1