MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. WAFER; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Catalog Number 54500229

Device Problem Off-Label Use (1494)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Because this event resulted in a serious injury, it is reportable per 21 cfr part 803.Not returned.

Event Description

In this case a dentist utilized a wafer to support the correction of the patient's occlusal situation surgically.However he did not order the correct type of wafer for the planned surgery.The surgery resulted in an open bite and the patient is refusing another surgical intervention.

• Brand Name: WAFER
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5025893
• MDR Text Key: 23885462
• Report Number: 3007362683-2015-00014
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54500229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention