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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM; SCREW 2.0X7MM

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BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM; SCREW 2.0X7MM Back to Search Results
Model Number N/A
Device Problem Extrusion (2934)
Patient Problem No Code Available (3191)
Event Date 08/04/2016
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.The user facility is foreign; therefore a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report three of three for the same event, reference 1032347-2016-00565 and 1032347-2016-00566.
 
Event Description
It was reported the lactosorb 2.0 mm system was implanted in the oral vestibule on (b)(6) 2016.Exposure of the plate was identified after two months.Inflammatory reaction was not observed.The plate and screws were removed on (b)(6) 2016.
 
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Brand Name
LACTOSORB TRAUMA PLATING SYSTEM
Type of Device
SCREW 2.0X7MM
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key6004441
MDR Text Key56757288
Report Number0001032347-2016-00567
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK992355
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 09/08/2016
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number915-2301-EA
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/08/2016
Initial Date FDA Received10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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