MAUDE Adverse Event Report: THOMMEN MEDICAL AG ELEMENT IMPL., PF 5.0, E 5.0, L 6.5; DENTAL IMPLANT

Model Number	4.13.907
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability not achieved, implant was completely covered with bone, no thread tap used.

• Brand Name: ELEMENT IMPL., PF 5.0, E 5.0, L 6.5
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): THOMMEN MEDICAL AG; neckarsulmstrasse 28; grenchen 2540 ; CH 2540
• MDR Report Key: 11683677
• Report Number: 3003184527-2021-00648
• Device Sequence Number: 16924409
• Product Code: DZE
• UDI-Device Identifier: 07640156470833
• UDI-Public: 07640156470833
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K093615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: 03/25/2020
• Device Model Number: 4.13.907
• Device Lot Number: 12060
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/19/2021
• 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: 38 YR