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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG (MDR) BEIN DENTAL ELEVATOR, 3MM, ANGLED; INSTRUMENT
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STRYKER LEIBINGER FREIBURG (MDR) BEIN DENTAL ELEVATOR, 3MM, ANGLED; INSTRUMENT Back to Search Results
Catalog Number 09-23201
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2015
Event Type  malfunction  
Event Description
It was reported that a customer purchased 6 elevators from stryker to use in their oral surgery department, which opened for business less than a year ago.All of their tips have either bent, chipped or broken during use.No adverse consequences were reported.
 
Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
Manufacturer Narrative
The reported event that the tip of the device has bent could be confirmed.The visual examination revealed that the tip of the device is bent compared to its original shape and shows several deformations due to mechanical overload.Both the dhr review and the hardness measurement performed showed that the device was manufactured according to specification.Most likely too high bending forces were applied to the tip during usage, leading to a deformation.Therefore the root cause can be tied to a user related issue.Indications for any material, manufacturing or design related problems were not determined in the investigation.
 
Event Description
It was reported that a customer purchased 6 elevators from stryker to use in their oral surgery department, which opened for business less than a year ago.All of their tips have either bent, chipped or broken during use.No adverse consequences were reported.
 
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Brand Name
BEIN DENTAL ELEVATOR, 3MM, ANGLED
Type of Device
INSTRUMENT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG (MDR)
boetzingerstr. 41
freiburg D-791 11
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG (MDR)
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
kelli dykstra
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key4890994
MDR Text Key6024550
Report Number0008010177-2015-00149
Device Sequence Number1
Product Code LRC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number09-23201
Device Lot Number600001460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/15/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/02/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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