MAUDE Adverse Event Report: AESCULAP AG ERGOPLANT ORAL SILICONE WEDGE #S; DENTAL

Model Number DX113

Device Problem Component Incompatible (1108)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the components were examined visually.The products with the reference code dx113 are made completely out of silicone.They do not have a drilling made of metal, and therefore they do not have a gap where the residues remain.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.No failure could be detected.The mentioned failure cannot occur on dx113.An internal inspection was initiated ((b)(4)).

Event Description

It was reported that there was an issue with a oral silicone wedge.According to the customer it was reported that the product cannot be cleaned properly.During a routine check the customer found residues between the metal insert and the silicone (protein test was positive).There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00176 ((b)(4) dx115).

Manufacturer Narrative

Additional case created.See b5.

Event Description

Additional product with the notification number 400470331 was created.Awareness date is 04.28.2020.Associated medwatch report.9610612-2020-00175 (400472614 dx113).9610612-2020-00176 (400472615 dx115).

Manufacturer Narrative

After a closer examination of the article and the risk of the article, it was found that the article in this size and design does not have a screw in the appropriate and claimed place.Therefore, the error pattern cannot occur with this article.Due to clarification, the report was reassessed and found to no longer require submission - no malfunction or serious injury.

• Brand Name: ERGOPLANT ORAL SILICONE WEDGE #S
• Type of Device: DENTAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10074928
• MDR Text Key: 191584310
• Report Number: 9610612-2020-00175
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX113
• Device Catalogue Number: DX113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1