MAUDE Adverse Event Report: MICERIUM S.P.A. ENA HFO / HRI TIPS; MATERIAL, TOOTH SHADE, RESIN

Catalog Number EHRTUD2

Device Problems Unintended Ejection (1234); Nonstandard Device (1420); Torn Material (3024)

Patient Problems Suffocation (2088); Tissue Damage (2104); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

The health risk classification is type 2: a situation in which the use of, or exposure to, a recalled device may cause temporary adverse health consequences or where the probability of serious adverse health consequence is remote.The recall was decided as a precautionary measure to remove any sort of residual risk.In fact, there could be a risk only if all of the following cases occur together: the product is used without using a dam (contrary to what is indicated in the instructions); the product is hardly forced and pushed (contrary to what a dentist should do to be able to make accurate and effective restoration); the product is used directly in the mouth; the product is used with a non-conventional dispenser, which does not block the piston at the stroke end; the tips were manufactured by one of the two damaged mold cavities.If all of these cases occur together, the tips may break down in the mouth, and in this case they could release plastic and composite residues.These plastic and composite elements could be aspirated or swallowed.Corrective actions: cause removal.In order to avoid that a similar situation reoccur the mould has already been replaced with a new one (where the cavities are identifiable with letters, and not with numbers), and all the stock coming from the defective tracks was eliminated.More intensive quality controls have been established.Non conformity solutions: an urgent field safety notice about this issue was sent to our u.S.Agent ((b)(4).) on friday july 15th.(b)(4), and informed us about sells in u.S.A.On friday july 15th.Only one u.S.Customer bought products coming from this lot, and (b)(4) immediately tried to recall those products.The doctor had bought 2 ehrtud2, lot 2015006969.When (b)(4) got in touch with him he had already used both of them without any problem.Important note on solution and communication times: even if micerium was reasonably sure that the problem wouldn't have had any practical impact, all actions to ward off even the most remote risk were immediately implemented and carried out.At the present date, all the operations necessary for the solution both of the cause and the non-compliance were completed.

Event Description

This product is a dental filling material, which is filled in a quantity of 0.3 g in so-called tips.The tips are inserted in an applicator ("dispenser") and the material can either be expressed outside of the mouth or applied by the dentist directly into the dental cavity.Regarding the product, it has been noticed for the first time during part of the quality control at (b)(4) that some tips burst at certain points during the application and that some parts can also be torn off.In the course of further research, it was determined that the dental filling material meets our quality criteria and that this can be excluded as the cause of the error.Instead, a material error of the tips has been determined as the cause.The injection mold for producing the tips is damaged by wear and tear at certain points, so that the plastic shows reduced mechanical stability.By far not all tips are affected, but only those that derive from two (of eight) certain cavities: the number 4 and the number 5.Initially this situation did not appear to be a risk for patients.However, further studies let (b)(4) arrive to the following conclusion: in (b)(4) opinion, the breakage of tips can lead to the following possible hazards: ingestion of plastic parts by the patient: the mere size of the plastic fragments does not pose a risk to the patient.However, some of the fragments have sharp edges which gives rise to the danger that, when swallowed, the parts could injure the esophagus and/or get stuck in it.In such a case, emergency medical care could become necessary.Aspiration: the aspiration of tips fragments could lead to respiratory disorders and could, in a worst case scenario, affect the respiratory system in a life-threatening way (risk of suffocation).Then inhaling a foreign object, immediate removal of this object can be lifesaving.Emergency medical care is to be provided by the attending physician.So far, this behavior of tips was not reclaimed by any customer nor have any patients come to harm.Furthermore, they consider this probability to be extremely low.However, due to the fact that the risks cannot be completely excluded they informed the (b)(6) ministry of health.We became aware on the type of risk of health on july 12th 2016 when (b)(4) sent us the request of (b)(6) ministry of health to inform all ue authorities where involved tips have been sold.From our evaluation, the risk of health is virtually non-existent, for the following reasons: the ena hri composite instruction reports the sentence: "we recommend the use of a rubber dam", which completely avoid the risk of swallowing or vacuum residues of composite or of the container in case of breakage.The possibility that this break takes place is very remote: after almost six months of sales of these tips we didn't receive any complaint and also centrix informed (b)(4), they didn't receive any.We weren't able to break any tips in micerium, also subjecting them to a very high load and pressure.The most of dispensers do not allow the piston to be able to push further, once arrived at the stroke end.Even if the tips break, the fact that the composite is swallowed by the patient would be a common risk for each restoration if a dam is not used.The plastic residues do not appear to be dangerous if swallowed or aspirated.Taking all of the above points, in conclusion, we believe that risks to users are virtually non-existent, and completely in line with those mentioned in the risk analysis but anyway we decided to voluntarily recall the involved lots with the aim of rendering ineffective any residual risk.We wrote the (b)(4) on (b)(6) 2016.All those tips which were used in the meanwhile, worked perfectly and won't be recalled (even as they are disposable).There is no risk both for patients and professionals who already used the tips.

• Brand Name: ENA HFO / HRI TIPS
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): MICERIUM S.P.A.; via g. marconi 83; avegno, ge 16036 ; IT 16036
• Manufacturer (Section G): CENTRIX, INC.; 770 river road; shelton CT 06484
• Manufacturer Contact: diego conca ; via g. marconi 83; avegno, ge 16036 ; IT 16036 ; 1857887870
• MDR Report Key: 5999208
• MDR Text Key: 57270259
• Report Number: 3004130302-2016-00001
• Device Sequence Number: 0
• Product Code: EBF
• Reporter Country Code: IT
• PMA/PMN Number: K062906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: EHRTUD2
• Device Lot Number: 2015006969
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other