MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM; DENTAL IMPLANT

Catalog Number XIFNT410

Device Problems Device Packaging Compromised (2916); Device-Device Incompatibility (2919); Compatibility Problem (2960)

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

Event Date 10/24/2015

Event Type  malfunction  

Event Description

The doctor reported that the implant size did not correspond to the label on the package.

Manufacturer Narrative

(b)(4).Visual and photographic inspection of the returned device showed damage consistent with removal with forceps.A device history record review and inspection for size features, diameter and length concluded that the device dimensions are according to specification.The complaint is unconfirmed.No definite cause could be determined.Additional information: expiration date and udi added; date added; checked boxes for additional information and device evaluation; checked box yes for device evaluated by manufacturer; and evaluation codes added.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 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: 5245991
• MDR Text Key: 32143187
• Report Number: 0001038806-2015-00851
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

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: Dentist
• Device Expiration Date: 07/07/2019
• Device Catalogue Number: XIFNT410
• Device Lot Number: 2015061382
• Other Device ID Number: (01)00844868021957(17)20190707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1215-2014
• Patient Sequence Number: 1
• Patient Age: 47 YR