MAUDE Adverse Event Report: INSTITUT STRAUMANN AG SP, 3.3MM RN, SLACT. 12MM, TIZR, GUID.; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Roxolid TL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Pain (1994); Fibrosis (3167); Swelling/ Edema (4577)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The batch number could not be verified due to incomplete or missing information and / or product from the customer.Our manufacturing q-system assures that production and process controls are in place to ensure that batches confirm to the applicable specifications before they're distributed.The loss of an endosseous dental implant after successful osseointegration and restoration is a known inherent risk of the procedure.Implants may have to be removed in case one or more of the implant success criteria are not met.Implant success criteria according to buser et al.(1991) are: absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia.Absence of a recurrent peri-implant infection with suppuration.Absence of implant mobility.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2008 in the patient's mouth.Details of surgery: bone overheating.On (b)(6) 2020, loss of osseointegration was verified.Patient presented with poor oral hygiene.The device was forwarded to the manufacturer.At the event the patient experienced: infection, peri-implantitis, pain, mobility, swelling and fistula.No further patient complications were reported.

• Brand Name: SP, 3.3MM RN, SLACT. 12MM, TIZR, GUID.
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 11726087
• Report Number: 0009613348-2021-27681
• Device Sequence Number: 11720897
• Product Code: DZE
• UDI-Device Identifier: 07630031715678
• UDI-Public: 07630031715678
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K090260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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 Model Number: SLActive Roxolid TL
• Device Catalogue Number: 033.453G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2021
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2021
• 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: 50 YR