MAUDE Adverse Event Report: DENTIUM USA SUPERLINE; ENDOSSEOUS DENTAL IMPLANT

Model Number FX4514SWC

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 01/19/2014

Event Type  Injury  

Event Description

After performing a sinus lift, the dentist implanted (b)(4) into the pt's #2 tooth location.The doctor stated the implant went into the sinus and the sinus membrane was penetrated causing bleeding and spinning of the implant.The implant was removed.The doctor replaced with a shorter length implant plus performed inferior sinus lift and bone addition.

Manufacturer Narrative

Conclusion: based on inspection results and the dhr review, the returned product has been found to be within specification.Therefore, the implant failure is most likely due to causes other than product such as surgical mistake, bone quantity, pt medical history, or pt behavior.

• Brand Name: SUPERLINE
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): DENTIUM USA; 6761 katella ave.; cypress CA 90630
• Manufacturer Contact: sheryl higgins ; 6761 katella ave.; cypress, CA 90630
• MDR Report Key: 3703687
• MDR Text Key: 4336973
• Report Number: 3005503242-2014-00002
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: FX4514SWC
• Device Lot Number: B08WA286S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR