MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, Ø 4.8 MM RC, SLACTIVE 14 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	021.6114
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2009 in ada 19.On (b)(6) 2025, fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.
Additional Manufacturer Narrative
The batch number could be verified.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 fracture of a dental implant is a known long-term complication of endosseous dental implants.The manufacturers trend analysis confirms that the reported implant fracture rate associated with its dental implants is low and remains consistent with the experience as documented in the literature.There are different reasons why implants break and this problem has been illuminated by various authors (e.G.Maeglin 1988, beumer 1989, tetsch 1991, worthington 1992).Beumer and lewis 1989 report the following causes: a) production / design flaws b) inadequate fitting of the suprastructure c) occlusal overload d) bruxism e) bone resorption around the implants f) insufficient axle alignment of the implants g) trauma h) biomechanical causes i) design of the suprastructure.
Additional Manufacturer Narrative
The batch number could be verified.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 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: 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 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 (b)(6) 2009 in ada 19.On (b)(6) 2025, loss of osseointegration was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.

• Brand Name: BL, Ø 4.8 MM RC, SLACTIVE 14 MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer (Section G): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 23574707
• Report Number: 0009613348-2025-017745
• Device Sequence Number: 10272807
• Product Code: DZE
• UDI-Device Identifier: 07630031707239
• UDI-Public: 07630031707239
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 11/30/2013
• Device Catalogue Number: 021.6114
• Device Lot Number: P1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/22/2025
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2008
• 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: 44 YR
• Patient Sex: Male