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Adverse Event Report

DENTAL-EZ, INC. DEN-TAL-EZ TRACK MOUNTED LIGHT DENTAL OPERATORY TRACK MOUNT LIGHT   back to search results
Model Number DISTINCTION SERIES LIGHT
Event Description

The track mounted light separated from its carrier unit causing the light and part of its assembly to fall onto the pt hitting pt in the groin area. The tube arm is installed into the carrier, and is secured with recessed hex set screws and a rolled pin is inserted through the aligning holes. The rolled pin was installed through the first hole but not driven through the mating tube support holes. Over time the set screws were not enough to maintain holding the light into its correct position.

 
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Brand NameDEN-TAL-EZ TRACK MOUNTED LIGHT
Type of DeviceDENTAL OPERATORY TRACK MOUNT LIGHT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DENTAL-EZ, INC.
101 lindenwood dr., ste 225
valley brooke corporate ctr
malvern PA 19355
Device Event Key265006
MDR Report Key273774
Event Key256670
Report NumberMW1018671
Device Sequence Number1
Product CodeEAZ
Report Source Voluntary
Report Date 04/12/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberDISTINCTION SERIES LIGHT
Device Catalogue Number3544-122
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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