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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTEX MEDICAL BA-320-185; BONE ANCHOR

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BIOTEX MEDICAL BA-320-185; BONE ANCHOR Back to Search Results
Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2014
Event Type  malfunction  
Event Description
Following completion of procedure, it was discovered during anchor bolt removal that the anchor bolt was broken.The break was at the point of attachment of threads.The surgeon opted to leave in the small plastic threads in place rather than remove.
 
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Brand Name
BA-320-185
Type of Device
BONE ANCHOR
Manufacturer (Section D)
BIOTEX MEDICAL
houston TX 77054
Manufacturer Contact
8058 el rio
houston, TX 77054
7137410111
MDR Report Key4102325
MDR Text Key4720587
Report Number3005726841-2014-00007
Device Sequence Number1
Product Code HOA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/28/2014
Initial Date FDA Received08/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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