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	Tissue Damage (2104); Sinus Perforation (2277)
Date of Event	08/01/2018
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) 2018 in fdi 16.Details of surgery: sinus perforation and sinus augmentation.On (b)(6) 2018, non-osseointegration was verified.Patient presented with bone type iv and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.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: 9499209
• Report Number: 0009613348-2019-53058
• Device Sequence Number: 14198583
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/19/2019
• Report Date (Section F): 10/09/2018

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: 10/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2019
• Device Age: 63 MO
• Event Location: Other
• Date Report to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 12/19/2019
• 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: 56 YR