MAUDE Adverse Event Report: INSTITUT STRAUMANN AG BL, Ø 3.3MM NC, SLACT. 8MM, RXD, GUIDED; ENDOSSEOUS DENTAL IMPLANT

Model Number	SLActive Roxolid BL
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	01/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report late due to asr to individual reporting transition per fda letter dated june 28, 2019.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in fdi 44.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.

• Brand Name: BL, Ø 3.3MM NC, SLACT. 8MM, RXD, GUIDED
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 9799214
• Report Number: 0009613348-2020-15428
• Device Sequence Number: 643457
• Product Code: DZE
• UDI-Device Identifier: 07630031706393
• UDI-Public: 07630031706393
• Combination Product (Y/N): N
• Initial Reporter Country: TR
• PMA/510(K) Number: K083550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/06/2020
• Report Date (Section F): 02/05/2020

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: 05/03/2020
• Device Model Number: SLActive Roxolid BL
• Device Catalogue Number: 021.2208G
• Device Lot Number: JN240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2020
• Device Age: 56 MO
• Event Location: Other
• Date Report to Manufacturer: 02/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/06/2020
• 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: 61 YR