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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTEX, INC. BA-320-185 BONE ANCHOR

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BIOTEX, INC. BA-320-185 BONE ANCHOR Back to Search Results
Lot Number 142045
Device Problems Break; Material Fragmentation; Material Integrity Problem
Event Date 08/07/2014
Event Type  Malfunction  
Event Description

During removal of bone anchor, it was discovered the last few threads were broke off the bone anchor. The surgeon recovered the threads. Pt was closed with suture as usual.

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Brand NameBA-320-185
Type of DeviceBONE ANCHOR
Manufacturer (Section D)
houston TX 77054
Manufacturer Contact
8058 el rio st.
houston , TX 77054-4185
MDR Report Key4095491
Report Number3005726841-2014-00008
Device Sequence Number1
Product CodeHOA
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 09/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device EXPIRATION Date02/01/2016
Device LOT Number142045
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial