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

Model Number DX114

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with ergoplant oral silicone wedge.According to the complaint description it was reported that the product cannot be cleaned properly.According to the customer, the product cannot be cleaned properly.During a routine check, the customer has found residues between the metal insert and the silicone (protein test positive).There was no patient harm.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

General information: we received a complaint about oral silicone wedges from the (b)(6) university, germany.This case is related to case (b)(4)/ (b)(4)/ (b)(4).The 2 devices dx114 are dealt with in this 8d report.Consequences for the patient: according to the available information, there were no negative consequences for patient.Failure description: there are discolorations and residues remained at the transition between metal part and silicone.2 investigation: the components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".See also psc (b)(4).In-house analysis: under microscopic enlargement it can be seen that the metal part is covered with a thin transparent silicon layer.This layer shows several damages tears.Several residues/contaminations have been deposited in this area.Inspection of unused stored goods: the stored goods show also a thin silicon layer which covers the metal part.This silicon layer shows also partly damages.At this stage of investigation we assume a potential manufacturing error therefore the complaint was forwarded to the manufacturer, as this product is manufactured by third party.Up to now the investigation/statement from the manufacturer is still pending.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: at that time it is not possible to determine a clear conclusion and root cause for the mentioned failure.Rationale due to the circumstance that a statement/investigation from the manufacturer side still await it is not possible to determine a root cause for the mentioned failure.The investigation is ongoing.Corrective action: a product safety case (psc) was created.

Manufacturer Narrative

Updated investigation: psc added.Investigation results: there are discolorations and residues remained at the transition between metal part and silicone.Visual investigation: under microscopic enlargement it can be seen that the metal part is covered with a thin transparent silicon layer.This layer shows several damages (tears).Several residues/contaminations have been deposited in this area.At this stage of investigation we assume a potential manufacturing error therefore the complaint was forwarded to the manufacturer, as this product is manufactured by third party.Up to now the statement from the manufacturer is still pending.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and measures: at that time it is not possible to determine a clear conclusion and root cause for the mentioned failure.Due to the circumstance that a statement/investigation from the manufacturer side still await it is not possible to determine a root cause for the mentioned failure.The investigation is ongoing.As a preventive measure a internal inspection was opened under a product safety case (psc) and since no statement of the manufacturer is available, the articles are no longer distributed.

• Brand Name: ERGOPLANT ORAL SILICONE WEDGE #M
• Type of Device: DENTAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10002055
• MDR Text Key: 189979258
• Report Number: 9610612-2020-00152
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX114
• Device Catalogue Number: DX114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1