MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Weight: weight unknown / not provided.Date of event: date of event unknown / not provided.Brand name: brand name unknown / not provided.Common device name: device product code unknown / not provided.Catalog, lot and udi number unknown / not provided.Pma/510(k) number not available.

Event Description

Patient came to medical office several times due to mobility of the crown, the screw was adjusted in several occasions but it stills having mobility, the screw is stripped out.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' upon investigation it was determined that the screw is a 3rd party item.

Event Description

No further event information is available at the time of this report.

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11117286
• MDR Text Key: 226313610
• Report Number: 0001038806-2021-00016
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR