MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MD SERIES LONG ANGLED ATTACHMENT; UNIT, OPERATIVE DENTAL

Model Number 5100015272

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2020

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Additional information: b5 h3 other text : device not available.

Event 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.

• Brand Name: MD SERIES LONG ANGLED ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10634414
• MDR Text Key: 209974466
• Report Number: 0001811755-2020-02604
• Device Sequence Number: 1
• Product Code: EIA
• UDI-Device Identifier: 04546540391810
• UDI-Public: 04546540391810
• Combination Product (y/n): N
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5100015272
• Device Catalogue Number: 5100015272
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1