MAUDE Adverse Event Report: HIOSSEN ET III SA FIXTURE; DENTAL IMPLANT

Model Number	CET3R4010S
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is reported to hiossen that a fracture had occured to female patient in her at 60's mid by dental office located in la.The doctor said the patient did not come to office for the follow-up check-ups during the year even though the dental practice had contacted her several times.The implant was not returned to the manufacturer therefore we were unable to do an investigation on the product.Therefore, the limited investigation was performed using the records pertaining to lot# h1e14a063 : device history records, manufacturing batch record, inspection record, raw material record, and return records.All of records showed the ti material and implant were manufactured according to the standards and all acceptance criteria have met the specifications.There were 9 returns of that lot # over a 2 year period ( 2014~2015 ), all the returns were related to size exchanges.This is a only case for complaint of a fracture.No future investigation was done, due to the actual implant not being available for physical evaluation.A more detailed and comprehensive investigation of the possible caused could be completed if the product was available.The reason why we are being late to submit this report was that we had waited the emdr account approval and set up period recently.Scientific advisory board review: hiossen's scientific advisory board reviewed the available material ( i.E.Radiographs ) and theorized the potential reasons behind the implant fracture.Radiographic comments : radiographs of the placement and healing show that the apex of the implant successfully integrated, but the upper portion still lacked complete bone integration.Final radiograph of the fractured implant seemed to show the point of fracture is where the complete integration and improper integration meet.Possible causes of fixture fracturing : based on the materials provided (radiographs), it is assumed that there were several possibilities that caused the fracture.Insufficient crestal hard tissue to support the upper portion of the implant from mastication & sheering forces.Overloading ot bruxism could have attributed to the fracturing of the implant.Caution : it is the advisory boards strong opinion that the implant remaining in the patient's jaw be removed as soon as possible.Potential issues may arise if not removed.No product returned to manufacturer.
Event or Problem Description
It was reported that the placed implant had been fractured in the patient's mouth after 23 months of implantation.

• Brand Name: ET III SA FIXTURE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HIOSSEN; 85 ben fairless dr.; fairless hills PA 19030
• MDR Report Key: 6224684
• Report Number: 3007135442-2016-00002
• Device Sequence Number: 970215
• Product Code: NHA
• UDI-Device Identifier: 00814913021034
• UDI-Public: 00814913021034
• Combination Product (Y/N): N
• PMA/510(K) Number: K140934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 02/09/2019
• Device Model Number: CET3R4010S
• Device Catalogue Number: CET3R4010S
• Device Lot Number: H1E14A063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 01/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR