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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTEOMED EXTREMILOCK ANKLE PLATING SYSTEM 9H FIBULA FRACTURE PLATE, RIGHT

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OSTEOMED EXTREMILOCK ANKLE PLATING SYSTEM 9H FIBULA FRACTURE PLATE, RIGHT Back to Search Results
Catalog Number 336-5209
Device Problems Bent (1059); Use of Device Problem (1670)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 03/09/2018
Event Type  malfunction  
Event Description
On 03/12/2018, osteomed was notified of an incident concerning one of our implant devices. Per the distributor, the plate was implanted in (b)(6) 2017. However, they recently identified that the plate was bent and needed to be explanted.
 
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Brand NameEXTREMILOCK ANKLE PLATING SYSTEM
Type of Device9H FIBULA FRACTURE PLATE, RIGHT
Manufacturer (Section D)
OSTEOMED
3885 arapaho road
addison TX 75001
Manufacturer (Section G)
OSTEOMED
3885 arapaho road
addison TX 75001
Manufacturer Contact
latoia phillips
3885 arapaho road
addison, TX 75001
MDR Report Key7388965
MDR Text Key104263784
Report Number2027754-2018-00009
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K133691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number336-5209
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/02/2018 Patient Sequence Number: 1
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