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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS HALLU- FIX ABLATION SET HALLU-FIX

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ASCENSION ORTHOPEDICS HALLU- FIX ABLATION SET HALLU-FIX Back to Search Results
Catalog Number XXX-HALLU-FIX:
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Injury (2348)
Event Date 05/11/2019
Event Type  Injury  
Manufacturer Narrative

Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.

 
Event Description

It was reported the screwdrivers were of an incorrect size. The patient was under anesthesia and surgery had to be postponed. The patient experienced an unnecessary hospital admission and further surgery a week later after the correct screwdriver was available.

 
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Brand NameHALLU- FIX ABLATION SET
Type of DeviceHALLU-FIX
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
8700 cameron road #100
8700 cameron road #100
austin TX 78754
Manufacturer (Section G)
ASCENSION ORTHOPEDICS
8700 cameron road #100
austin TX 78754
Manufacturer Contact
vivian nelson
1000 campus drive
princeton, NJ 08536
6099362319
MDR Report Key10275790
MDR Text Key202935764
Report Number9615741-2020-00005
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
PMA/PMN NumberK021626
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberXXX-HALLU-FIX:
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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