MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number XIFNT411

Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)

Patient Problems Tissue Damage (2104); No Information (3190)

Event Date 11/25/2016

Event Type  Injury  

Event Description

The dentist reported that implant was intended to be placed in a previous sinus elevation site.The implant went into the sinus, therefore implant was localized and removed in the same surgery.Site was not grafted after removal of the implant, doctor had to perforate the sinus membrane to localize the implant.Another surgery is planned ( sinus elevation approaching by the lateral site) same site that the previous implant placement, and conventional restorative method.

Manufacturer Narrative

The complaint couldn¿t be verified as an x-ray was not provided by doctor showed the position of the implant in the maxillary sinus.The implant appears to be in functional condition.The device history record review was performed and did not identify any non-conformances.There were no manufacturing deviations identified which would cause or contribute to this complaint.A definitive root cause has not been determined.(b)(4).Device evaluated by manufacturer: change ¿no¿ to ¿yes.¿.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I IBERICA SL; c/islas baleares, 50; pol. ind. fuente del jarro; paterna, valencia
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6189384
• MDR Text Key: 62840966
• Report Number: 0001038806-2016-00360
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK130949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

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
• Device Operator: Dentist
• Device Expiration Date: 07/07/2021
• Device Catalogue Number: XIFNT411
• Device Lot Number: 2016070008
• Other Device ID Number: SEE NARRATIVE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention