MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 13MM; DENTAL IMPLANT

Catalog Number XIITP6513

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Nerve Damage (1979)

Event Date 03/25/2017

Event Type  Injury  

Event Description

The dentist reported that the implant was removed due to nerve damage/numbness.The implant was removed and the site bone grafted.

Manufacturer Narrative

An osseotite tapered certain prevail implant (xiitp6513) was returned.Visual inspection of the as received products identified general signs of usage around the external threads and the internal hex.The complaint does not allege a failure that can be tested.Visual comparison of drawing 2015041139 rev c was consistent with the design of the implant and did not identify any manufacturing deviation.Review of the implant dhr did not provide any indication of a manufacturing deviation or material deficiencies that would contribute to the reported event.Document type(s) reviewed: biomet 3i dental implant ifu (p-iis086gi rev.F 11/2015).Information identified: potential adverse events: potential adverse events associated with the use of dental implants may include: failure to integrate, loss of integration, dehiscence requiring bone grafting, perforation of the maxillary sinus, inferior border, lingual plate, labial plate, inferior alveolar canal, or gingiva, infection as reported by abscess, fistula, suppuration, inflammation, or radiolucency, persistent pain, numbness, paresthesia, hyperplasia, excessive bone loss requiring intervention, implant breakage or fracture, systemic infection, nerve injury, ingestion, aspiration and/or swallowing.The complaint could not be verified, as there were no manufacturing deviations identified with the implant that could cause or contribute to the reported event.The exact details of the device usage are unknown.The conditions under which the implant was subjected in the patient¿s mouth are unknown.No radiographs or photographs of the implant site were provided.Therefore, based on the information provided, a definitive cause originating from the anatomical and/or use conditions cannot be determined.(b)(4).

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 13MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I DENTAL IBERICA SL; c/islas baleares, 50; pol. ind. fuente del jarro; valencia
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6610992
• MDR Text Key: 76658321
• Report Number: 0001038806-2017-00281
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

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: 05/01/2020
• Device Catalogue Number: XIITP6513
• Device Lot Number: 2015041139
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/05/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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
• Patient Age: 38 YR