MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Catalog, lot udi number and expiry date unknown / not provided.Pma/510(k) number not available.Device manufacture date.Since the lot number and device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.

Event Description

It was reported that patient came to medical office with crown mobility.

• Type of Device: DENTAL 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 10828354
• MDR Text Key: 217436797
• Report Number: 0001038806-2020-01806
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/12/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 46 YR
• Patient Weight: 62