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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I; ABUTMENT SCREW
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BIOMET 3I; ABUTMENT SCREW Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
 
Event Description
It was reported that the unknown biomet abutment screw was fractured.
 
Manufacturer Narrative
One osseotite® tapered certain® implant 3.25 x 10mm (xifnt3210) was returned for investigation.Visual inspection of the as returned product identified that the implant is damaged and chipped at the collar.The internal drive feature could not be inspected in the current condition, as the removal tool could not be disengaged.The reported event was unconfirmed following inspection, as the reported screw could not be seen in the returned condition.Therefore, based on the evaluation, for the received implant: the device malfunction did occur, as the implant was noted to be damaged.However, the malfunction of the fractured screw is non-verifiable as the screw could not be seen.Thus reported event was unconfirmed following inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.A singular root cause could not be determined.The following section have been corrected.Product not returned to manufracturer.
 
Event Description
No further event information available at the time of this report.
 
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Type of Device
ABUTMENT SCREW
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key8203864
MDR Text Key131698477
Report Number0001038806-2018-01061
Device Sequence Number1
Product Code NHA
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 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/29/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received04/04/2019
Supplement Dates FDA Received04/05/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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