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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  Injury  
Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight: not provided.Event date: not provided.Device brand name: not provided.Device product code: not provided.Device catalog/ lot number: not provided.Pma/510(k) number: not provided.
 
Event Description
It was reported that unknown biomet screw fractured within the implant.Screw fragment was unable to be removed and implant was removed instead.Tooth location 30.
 
Manufacturer Narrative
A fragment of the reported unknown biomet screw along with the 3i t3® tapered implant 6/5 x 13mm (bopt6513) was returned for investigation.Visual inspection of the as returned product identified significant damage about the implant threads and drive feature.The drive feature contains a piece of an unknown biomet screw.The screw could not be disengaged from the implant.No pre-existing conditions were noted on the per.The reported product was located on tooth # 30 (universal) and used for approximately 7 months.The reported event could not be recreated due to the nature of the dental device and event (fracture).Dhr review could not be performed, as the lot number associated with the reported product is 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.October post market trending was reviewed and there were no actionable events or corrective actions for the reported event (screw fracture) or product (bopt6513 & biomet internal hex screws).Therefore, based on the available information, device malfunction has occurred.The implant and fractured screw fragment could not be disengaged.The reported fracture event was confirmed following inspection of the returned devices.The following sections have been updated: g7: checked "follow-up".H2: checked follow-up type.
 
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 Key10610501
MDR Text Key209334470
Report Number0001038806-2020-01466
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 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BOPT6513
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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