MAUDE Adverse Event Report: BIOMET 3I RADIOGRAPHIC TRANSPARENCY FOR CERTAIN AND EXTERNAL CONNECTION TAPERED IMPLANTS; RADIOGRAPHIC TRANSPARECY

Catalog Number ART1036

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation has confirmed that the radiographic transparency printed smaller than required; measuring approximately 7.8 x 10.2¿ instead of 8.5 x 11¿ as required.Inventory was contained through quality hold and non- conformance.Capa and an hhe were initiated and hhe risk assessment resulted in recall # z-0564-2016 being initiated.No reports of injury have been received to date; however the degree to which the implant were undersized on the transparency does present a potential to cause injury, therefore this event is being reported.

Event Description

It was reported that the transparency is smaller than the usual one, so it is smaller than the regular size of an implant.

• Brand Name: RADIOGRAPHIC TRANSPARENCY FOR CERTAIN AND EXTERNAL CONNECTION TAPERED IMPLANTS
• Type of Device: RADIOGRAPHIC TRANSPARECY
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6123955
• MDR Text Key: 60748840
• Report Number: 0001038806-2016-00305
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: PEXEMPT
• 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
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ART1036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0564-2016
• Patient Sequence Number: 1