MAUDE Adverse Event Report: BIOMET 3I UNKNOWN ZIMMER IMPLANT; ABUTMENT SCREW

Device Problems Failure To Adhere Or Bond (1031); Corroded (1131); Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient is experiencing a pin loosening and corrosion.

Manufacturer Narrative

It has been confirmed that this is a dental implant.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A singular root cause cannot be determined.

Event Description

It was reported that an unknown abutment screw loosened.

• Brand Name: UNKNOWN ZIMMER IMPLANT
• Type of Device: ABUTMENT SCREW
• 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 33410-0708 ; 5617766700
• MDR Report Key: 5936649
• MDR Text Key: 54207514
• Report Number: 0001822565-2016-03181
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other