MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPLANT, PF 3,5, E 3,5 L 14,0; DENTAL IMPLANT

Model Number	4.13.920
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
No osseointegration, immediate implantation, inadequate bone quality, smoker, infection, swelling, pain.

• Brand Name: ELEMENT IMPLANT, PF 3,5, E 3,5 L 14,0
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen, 2540 ; SZ 2540
• MDR Report Key: 7234438
• Report Number: 3003184527-2018-00056
• Device Sequence Number: 1017297
• Product Code: DZE
• UDI-Device Identifier: 07640156471458
• UDI-Public: 7640156471458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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: 12/08/2019
• Device Model Number: 4.13.920
• Device Lot Number: 11546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2018
• Initial Report FDA Received Date: 02/01/2018
• 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: 34 YR