MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,4.8MM RC, SLACT.8MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Roxolid BL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fibrosis (3167)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 3.On (b)(6) 2021, loss of osseointegration was verified.Patient presented with inadequate bone quality/quantity and previous bone augmentation.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis, pain, mobility and inflammation.No further patient complications were reported.

• Brand Name: BL,4.8MM RC, SLACT.8MM,ROXOLID,GUIDED
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 11544798
• Report Number: 0001222315-2021-04790
• Device Sequence Number: 14464963
• Product Code: DZE
• UDI-Device Identifier: 07630031707253
• UDI-Public: 07630031707253
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121131
• Summary Report (Y/N): Y
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/22/2021
• Report Date (Section F): 02/24/2021

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: 07/23/2023
• Device Model Number: SLActive Roxolid BL
• Device Catalogue Number: 021.6308G
• Device Lot Number: RL474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2021
• Device Age: 31 MO
• Event Location: Other
• Date Report to Manufacturer: 02/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/22/2021
• 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: Required Intervention
• Patient Age: 75 YR