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

Catalog Number	AET3M3511S
Health Effect - Clinical Code	Debris, Bone Shedding (1803)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No surgery and patient information provided by customer.Hiossen had investigated using the record pertaining to this batch number : device history record , manufacturing batch record, all inspection records , raw material record, all return record related unsuccessful implantation in same batch.All of records showed that there were no fracture related problem.The implant were manufactured according to the standard and all acceptance criteria have been met the required specifications.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.Possible causes of fixture fracturing based on the material 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 mystification & sheering forces.Overloading or bruxism could have attributed to the fracturing of the implant.
Event or Problem Description
Implant fractured leading to significant bone loss.

• Brand Name: ET III SA FIXTURE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HIOSSEN INC.; 85 ben fairless dr.; fairless hills PA 19030
• MDR Report Key: 7527569
• Report Number: 3007135442-2017-00003
• Device Sequence Number: 1176343
• Product Code: DZE
• UDI-Device Identifier: 00814913020587
• UDI-Public: 00814913020587
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K140934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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: Dentist
• Device Expiration Date: 03/19/2019
• Device Catalogue Number: AET3M3511S
• Device Lot Number: H1E14B008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention