MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, Ø 3.3 MM NC, SLACTIVE 14 MM, TIZR; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Roxolid BL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2013 in ada 8.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2022, fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.

• Brand Name: BL, Ø 3.3 MM NC, SLACTIVE 14 MM, TIZR
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 15626715
• Report Number: 0001222315-2022-22160
• Device Sequence Number: 20419289
• Product Code: DZE
• UDI-Device Identifier: 07630031706447
• UDI-Public: 07630031706447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/18/2022
• Report Date (Section F): 09/21/2022

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: 06/30/2017
• Device Model Number: SLActive Roxolid BL
• Device Catalogue Number: 021.2214
• Device Lot Number: EM006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2022
• Device Age: 122 MO
• Event Location: Other
• Date Report to Manufacturer: 09/21/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female