MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL,4.8MM RC, SLACT.10MM,ROXOLID,GUIDED; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLACTIVE ROXOLID BL
Medical Device Problem Codes	Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fibrosis (3167)
Date of Event	07/06/2019
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 are distributed.The removal of a dental implant during surgery without the replacement of another dental implant is a known inherent risk of the procedure due to either lack of primary stability of the implant (patienor procedure related).It may also include the removal of an implant after osseointegration due to either the clinician's or patient¿s decision.The manufacturer¿s trend analysis confirms that usually procedural errors and/or patient's condition contribute to the event.Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.
Event or Problem Description
The clinician reports that the day the implant was placed in fdi 36, failure occurred upon insertion.Patient presented with bone type iii.No product was returned to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.
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 are distributed.The non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants.Most implant failures occur before occlusal loading (analainen et al.2013, koldsland et al.2009).Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al.2008).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: 1.Absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia 2.Absence of a recurrent peri-implant infection with suppuration 3.Absence of implant mobility 4.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.
Event or Problem Description
The clinician reports the implant was inserted 2019-(b)(6)in fdi 36.On 2019-(b)(6), non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: BL,4.8MM RC, SLACT.10MM,ROXOLID,GUIDED
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 11888291
• Report Number: 0009613348-2021-36910
• Device Sequence Number: 3723998
• Product Code: DZE
• UDI-Device Identifier: 07630031707277
• UDI-Public: 07630031707277
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K121131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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 BL
• Device Catalogue Number: 021.6310G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2021
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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