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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I FIXTURE REMOVER SCREW M2.0
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BIOMET 3I FIXTURE REMOVER SCREW M2.0 Back to Search Results
Catalog Number FRS20
Device Problems Fracture (1260); Positioning Problem (3009)
Patient Problem Failure of Implant (1924)
Event Date 06/01/2016
Event Type  Injury  
Event Description
The dentist reported that two (2) unknown implants were removed due to the positioning of the implants.While removing the implants the frs20 fixture remover screws fractured inside the implants and the fixture removers.The dentist was unable to disengage the screws from the fixture removers.
 
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Brand Name
FIXTURE REMOVER SCREW M2.0
Type of Device
REMOVER 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
dania perez
4555 riverside drive
palm beach gardens, FL 33410
5617766700
MDR Report Key5768985
MDR Text Key48744385
Report Number0001038806-2016-00149
Device Sequence Number1
Product Code DZA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 06/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Catalogue NumberFRS20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2016
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/01/2016
Event Location Other
Date Report to Manufacturer06/06/2016
Date Manufacturer Received06/06/2016
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 N
Patient Sequence Number1
Treatment
FR415
Patient Outcome(s) Required Intervention;
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