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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BA-320-185 BONE ANCHOR

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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 06/20/2014
Event Type  Malfunction  
Event Description

A bone anchor was installed prior to mri in preparation for laser ablation procedure. It was determined that the pt still had orthodontics and these had to be removed prior to the mri/laser ablation procedure. The bone anchor was inadvertently broken during the process of removing the pts orthodontics prior to the laser ablation. The laser ablation procedure was successfully completed and the entry site was closed at the conclusion of the procedure with a small portion of the bone anchor thread left in pt's bone.

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Brand NameBA-320-185
Type of DeviceBONE ANCHOR
Manufacturer Contact
ashtok gowda
8058 el rio st.
houston, TX 77054
MDR Report Key4176259
MDR Text Key5025620
Report Number3005726841-2014-00006
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
Type of Report Initial
Report Date 07/23/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/25/2014
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