MAUDE Adverse Event Report: INSTITUT STRAUMANN AG S IMPL. Ø3.3 RN, SLACTIVE 8MM, ROXOLID®; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLACTIVE ROXOLID TL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Tissue Damage (2104)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2015 in fdi 36.On (b)(6) 2020, fracture of the implant was verified.Patient presented with bruxism.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were 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.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2015in fdi 36.On (b)(6) 2020 fracture of the implant was verified.Patient presented with bruxism.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: S IMPL. Ø3.3 RN, SLACTIVE 8MM, ROXOLID®
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 9923246
• Report Number: 0009613348-2020-22902
• Device Sequence Number: 3257200
• Product Code: DZE
• UDI-Device Identifier: 07630031715562
• UDI-Public: 07630031715562
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K083550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020
• Report Date (Section F): 03/20/2020

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: 07/31/2017
• Device Model Number: SLACTIVE ROXOLID TL
• Device Catalogue Number: 033.431S
• Device Lot Number: EP411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/19/2020
• Device Age: 92 MO
• Event Location: Other
• Date Report to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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: 48 YR