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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; Material Fragmentation; Material Integrity Problem
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 NameBA-320-185
Type of DeviceBONE ANCHOR
Manufacturer (Section D)
BIOTEX MEDICAL
houston TX 77054
Manufacturer Contact
8058 el rio
houston , TX 77054
7137410111
MDR Report Key4102325
Report Number3005726841-2014-00007
Device Sequence Number1
Product CodeHOA
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/27/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2014
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
Date Manufacturer Received07/28/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Initial

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