MAUDE Adverse Event Report: Institut Straumann AG TLX S ?5.5 WT, SLA? 6mm, RXD; Endosseous Dental Implant

Catalog Number	035.0706S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Fibrosis (3167)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2026 in ada 19.Details of surgery: primary stability not achieved.On (b)(6) 2026, 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: pain, mobility and bleeding.No further patient complications were reported.

• Brand Name: TLX S ?5.5 WT, SLA? 6mm, RXD
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Institut Straumann AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 50178560
• Report Number: 0001222315-2026-002382
• Device Sequence Number: 10035679
• Product Code: DZE
• UDI-Device Identifier: 07630031751799
• UDI-Public: 07630031751799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/07/2026
• Report Date (Section F): 08/07/2026

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 Catalogue Number: 035.0706S
• Device Lot Number: LHCV5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2026
• Device Age: 16 MO
• Event Location: Other
• Date Report to Manufacturer: 07/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• 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: 64 YR
• Patient Sex: Male