MAUDE Adverse Event Report: ZHERMACK S.P.A. ZETAPLUS L; MATERIAL, IMPRESSION

Catalog Number C100730

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problems Irritation (1941); Swelling (2091); Injury (2348)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr 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 while taking a dental impression with zeta plus, the material set very quickly and could not be removed from the patient's mouth.It was necessary to cut the impression tray and putty into several pieces by using cutters and cutting discs to release it from the patient's mouth.As a result, the patient's face is swollen, has a wounded mucosa of the lower jaw.Sachol and solcoseryl were applied directly on the patient's mucosa to alleviate irritation and accelerate healing of wounds of the mucosa.

Manufacturer Narrative

The device was evaluated and found to be within specification.Retain samples were also tested and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: ZETAPLUS L
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine, rovigo 45021 ; IT 45021
• Manufacturer (Section G): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine, rovigo 45021 ; IT 45021
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6261871
• MDR Text Key: 65143136
• Report Number: 9614794-2016-00003
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K935890
• 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,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C100730
• Device Lot Number: 243434
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR