MAUDE Adverse Event Report: BIOMET 3I; ABUTMENT SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.(b)(6).Device will not be returned.

Event Description

Doctor reported that the unknown lb abutment screw became loose in the patient's mouth one week after placement.

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.Based on the evaluation, device malfunction and the reported event could not be verified since the product was not returned and the lot or item number was not available for further investigation.As a result, the complaint is non-verifiable.A root cause cannot be determined.

Event Description

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

• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8202564
• MDR Text Key: 131604833
• Report Number: 0001038806-2018-01056
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Patient Sequence Number: 1
• Patient Age: 57 YR