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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW
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BIOMET 3I; DENTAL SCREW Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
 
Event Description
It was reported that a 3i implant placed (b)(6) 2016 the patient returned for the crown and was delivered (b)(6) 2017.The patient emailed today with the crown broken off.He was told by another dentist that the screw had broken off inside.
 
Manufacturer Narrative
The unknown screw and implant were not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported product was located on an unknown tooth site and used for approximately 4 years prior to the notification date.The reported event could not be recreated due to the nature of the dental device and event (fracture).The customer has not provided additional pictures or x-ray images of the product.Dhr review could not be performed, as the lot numbers associated with the reported product are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review could not be performed without relevant item and lot information.Based on the available information, device malfunction could not be verified and the reported events were non-verifiable.H3 other text : device not returned.
 
Event Description
No further event information available at the time of this report.
 
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Type of Device
DENTAL SCREW
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key10309140
MDR Text Key201885519
Report Number0001038806-2020-01018
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
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 Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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