MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPLANT, PF 6,0, E 6,0, L 6,5; DENTAL IMPLANT

Model Number	4.13.908
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability achieved, no osseointegration.Patient has blood coagulation disorder and diabetes mellitus.At time of surgery periodontal disease and local infection/subacute chronic osteitis.Mobility.

• Brand Name: ELEMENT IMPLANT, PF 6,0, E 6,0, L 6,5
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen, 2540 ; SZ 2540
• MDR Report Key: 8100153
• Report Number: 3003184527-2018-01199
• Device Sequence Number: 19232046
• Product Code: DZE
• UDI-Device Identifier: 07640156470819
• UDI-Public: 7640156470819
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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: Health Professional
• Device Expiration Date: 05/11/2021
• Device Model Number: 4.13.908
• Device Lot Number: 14002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/24/2018
• 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: Other
• Patient Age: 89 YR