MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S, Ø 3.3 MM, RN, SLA 8.0 MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLACTIVE ROXOLID TL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
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 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: production/design flaws, inadequate fitting of the suprastructure, occlusal overload, bruxism, bone resorption around the implants, insufficient axle alignment of the implants, trauma, biomechanical causes, design of the suprastructure.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2001 in fdi 11.On (b)(6) 2021, 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 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 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 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 2001-(b)(6) in the patient's mouth.On 2021(b)(6) fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.

• Brand Name: S, Ø 3.3 MM, RN, SLA 8.0 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: 12926666
• Report Number: 0009613348-2021-93749
• Device Sequence Number: 4957876
• Product Code: DZE
• UDI-Device Identifier: 07630031715562
• UDI-Public: 07630031715562
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K983742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2021
• 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): 01/27/2022

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: 043.131S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2022
• 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: 12/03/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 84 YR
• Patient Sex: Female