MAUDE Adverse Event Report: STRAUMANN MANUFACTURING INC. BLX SLA ACTIVE/BL SLA ACTIVE/BLT SL /BL SLA - IMPLANTS; ENDOSSEOUS DENTAL IMPLANT

Model Number BLX/BLT/BL

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2019

Event Type  Injury  

Event Description

Ai2o3 particles on titanium dental implant systems following sandblasting and acid-etching process https://www.Hindawi.Com/journals/ijbm/2019/6318429/ i demand what straumann withdraw / recall of blx/bl/blt/sla active/sla implants.Straumann advertises implants as 100% ai-free.Ai in bone and tissues oxidized to ai2o3 therefore, ai2o3 particles in implant surface are more dangerous than even implants alloy with ai contain.Clinicians should be able to expect a clean implant surface when treating their pts.Fda safety report id (b)(4).

• Brand Name: BLX SLA ACTIVE/BL SLA ACTIVE/BLT SL /BL SLA - IMPLANTS
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): STRAUMANN MANUFACTURING INC.
• MDR Report Key: 9848064
• MDR Text Key: 184270476
• Report Number: MW5093817
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: UZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BLX/BLT/BL
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention