MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S Ø 4.1MM RN, SLACTIVE® 16MM, TIZR, NTP; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Roxolid TL
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 28.Details of surgery: primary stability not achieved and implant surface not completely covered with bone.On (b)(6) 2020, non-osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: S Ø 4.1MM RN, SLACTIVE® 16MM, TIZR, NTP
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 9874843
• Report Number: 0009613348-2020-19985
• Device Sequence Number: 481028
• Product Code: DZE
• UDI-Device Identifier: 07630031715913
• UDI-Public: 07630031715913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/24/2020
• Report Date (Section F): 03/10/2020

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: 09/12/2024
• Device Model Number: SLActive Roxolid TL
• Device Catalogue Number: 033.535S
• Device Lot Number: YG496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2020
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 03/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/24/2020
• 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: 78 YR