MAUDE Adverse Event Report: HIOSSEN, INC. ETIII SA FIXTURE; DENTAL IMPLANT

Model Number	CET3R4011S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hiossen performed an extensive document review of lot# h1e12g070 - device history record, manufacturing batch record, inspection record, raw material record and returns record.All records show that the lot was manufactured with in specifications.Return records show that no fracture cases were reported.Since the device was returned, a through inspection using high powered microscope and mini sem was performed.It was determined that the internal hex received damage and is a possible point of weakening.Finally, hiossen reviewed the patient's records and x-rays.According to the x-rays, the implant site suffered bone loss about 2 years and 6 months after implantation, but no remediation or treatment was performed.Hiossen's conclusion based on the information collected is that the damaged internal hex reduced the implant's structural integrity but this alone would not fracture the implant.Since bone loss was observed, the support to the implant was slowly disappearing and thus metal fatique exponentially increase resulting in the fracture.
Event or Problem Description
On (b)(6) 2018, (b)(6) had his tooth #9 dental implant removed after 3 years and 4 months of implantation.According to the patient's chart, on (b)(6) 2018 the crown and abutment was disassembled and the prosthodontist discovered the implant was fractured.

• Brand Name: ETIII SA FIXTURE
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HIOSSEN, INC.; 85 ben fairless drive; fairless hills PA 19030
• MDR Report Key: 7736725
• Report Number: 3007135442-2018-00001
• Device Sequence Number: 16398586
• Product Code: DZE
• UDI-Device Identifier: 00814913021041
• UDI-Public: 00814913021041
• Combination Product (Y/N): N
• PMA/510(K) Number: K140934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2017
• Device Model Number: CET3R4011S
• Device Catalogue Number: CET3R4011S
• Device Lot Number: H1E12G070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/31/2018
• 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
• Patient Age: 21 YR
• Patient Weight: 73