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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I UNKNOWN BIOMET SCREW ABUTMENT SCREW

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BIOMET 3I UNKNOWN BIOMET SCREW ABUTMENT SCREW Back to Search Results
Model Number N/A
Device Problem Unintended Movement
Event Date 11/14/2018
Event Type  Malfunction  
Manufacturer Narrative

Zimmer biomet complaint (b)(4). Device catalog number and lot number not provided/unknown. Device not returned.

 
Event Description

It was reported that an unknown biomet screw loosened. The screw remains implanted. Tooth location 4.

 
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Brand NameUNKNOWN BIOMET SCREW
Type of DeviceABUTMENT 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 Key8278898
Report Number0001038806-2019-00071
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial,Followup
Report Date 04/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN BIOMET SCREW
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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