MAUDE Adverse Event Report: INSTITUT STRAUMANN AG TE, Ø 3.3 MM RN, SLACTIVE 10MM, ROXOLID®; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	033.752S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2017 in the patient's mouth.On (b)(6) 2017, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis, pain, mobility, swelling and inflammation.No further patient complications were reported.

• Brand Name: TE, Ø 3.3 MM RN, SLACTIVE 10MM, ROXOLID®
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 9523329
• Report Number: 0009613348-2019-54746
• Device Sequence Number: 459870
• Product Code: DZE
• UDI-Device Identifier: 07630031716484
• UDI-Public: 07630031716484
• Combination Product (Y/N): N
• PMA/510(K) Number: K081419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/27/2019
• Report Date (Section F): 12/10/2019

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: 05/31/2018
• Device Catalogue Number: 033.752S
• Device Lot Number: FR265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2019
• Device Age: 50 MO
• Event Location: Other
• Date Report to Manufacturer: 12/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/27/2019
• 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: 44 YR