MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP IMPL., 3.3MM RN, SLACTIVE 14MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Titanium TL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2015 in ada 12.On (b)(6) 2020, fracture of the implant was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.

• Brand Name: SP IMPL., 3.3MM RN, SLACTIVE 14MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 10515936
• Report Number: 0001222315-2020-10247
• Device Sequence Number: 19444328
• Product Code: DZE
• UDI-Device Identifier: 07630031714848
• UDI-Public: 07630031714848
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033984
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/10/2020
• Report Date (Section F): 08/17/2020

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: 05/31/2016
• Device Model Number: SLActive Titanium TL
• Device Catalogue Number: 033.154S
• Device Lot Number: AW653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/10/2020
• Device Age: 110 MO
• Event Location: Other
• Date Report to Manufacturer: 08/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/10/2020
• 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: 38 YR