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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS REMB DRILL MD SERIES MEDIUM STRAIGHT MICRODRILL ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS REMB DRILL MD SERIES MEDIUM STRAIGHT MICRODRILL ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100-015-250
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 08/09/2018
Event Type  malfunction  
Event Description
Elderly pt.Here for multiple teeth extractions and implants.While pt.Was still in surgery, he was burned on the right side of his lower lip by a drill being used.Per initial report, it was a stryker remi drill and reportedly the surgeon performing the procedure reported the hand piece was hot and he noticed the lip burn.The equipment was removed and placed out of service.Manufacturer response for stryker remi drill, stryker (per site reporter).No formal response; review pending.
 
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Brand Name
REMB DRILL MD SERIES MEDIUM STRAIGHT MICRODRILL ATTACHMENT
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo MI 49001
MDR Report Key7933433
MDR Text Key122643248
Report Number7933433
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5100-015-250
Device Catalogue Number5100-015-250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2018
Event Location Hospital
Date Report to Manufacturer10/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age24090 DA
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