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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015272
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Codes Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/11/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated during a procedure.  user facility reported a burn on the patient's cheek.No additional consequences reported.
 
Additional Manufacturer Narrative
Additional information: b5 h3 other text : device not available.
 
Event or Problem Description
The user facility reported that the device overheated during a procedure. the user facility reported a slight burn on the patient's cheek.An ointment was used to treat the burn.
 
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Brand Name
MD SERIES LONG ANGLED ATTACHMENT
Common Device Name
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10634414
Report Number0001811755-2020-02604
Device Sequence Number2630622
Product Code EIA
UDI-Device Identifier04546540391810
UDI-Public04546540391810
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K032117
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number5100015272
Device Catalogue Number5100015272
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/14/2020
Supplement Date Received by Manufacturer05/12/2021
Initial Report FDA Received Date10/06/2020
Supplement Report FDA Received Date05/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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