MAUDE Adverse Event Report: W AND H CANADA/USA IMPLANTMED; DENTAL DRILL

Model Number SI-95 IMPLANTMED

Device Problem Failure to Power Up (1476)

Patient Problem Sedation (2368)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

After patient was anesthetized, it was discovered the implanted drill, provided by oticon (b)(4), did not function.The surgery was cancelled.

• Brand Name: IMPLANTMED
• Type of Device: DENTAL DRILL
• Manufacturer (Section D): W AND H CANADA/USA; windsor, ontario ; CA
• Manufacturer Contact: carolina wessling ; datavagen 37b; askim ; SW ; 17486175
• MDR Report Key: 4993218
• MDR Text Key: 23719425
• Report Number: 3007367732-2015-00033
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SI-95 IMPLANTMED
• Device Catalogue Number: SI-915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2015
• Device Age: 4 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other