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Adverse Event Report

ACUMED ACUMED ORTHOPEDIC SCREWDRIVER   back to search results
Catalog Number HD-2500
Event Date 04/21/2004
Event Type  Other   Patient Outcome  Other;
Event Description

Hex driver tip broke. Tip stuck in shoulder rod screw. Larger incision required to remove tip.

 
Manufacturer Narrative

Tip exhibited twisting. Torsional failure. Possible excessive force. No conclusion can be drawn.

 
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Brand NameACUMED
Type of DeviceORTHOPEDIC SCREWDRIVER
Baseline Brand NameACUMED
Baseline Generic NameORTHOPEDIC SCREWDRIVER
Baseline Catalogue NumberHD-2500
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ACUMED
5885 nw cornelius pass rd.
hillsboro OR 97124
Manufacturer (Section D)
ACUMED
5885 nw cornelius pass rd.
hillsboro OR 97124
Manufacturer Contact
robert kottman
5885 nw cornelius pass road
hillsboro , OR 97124
(503) 627 -9957
Device Event Key515649
MDR Report Key526482
Event Key499738
Report Number3025141-2004-00002
Device Sequence Number1
Product CodeHXX
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberHD-2500
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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