MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE; VARIOUS, EBG, LLZ, DZE

Catalog Number 37504

Device Problem Positioning Failure (1158)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Because a second intervention is necessary, this event is reportable per 21 cfr part 803.

Event Description

In this case, a dentist planned to place two different implant systems (2 xive and 4 ankylos) in one patient.The dentist ordered one surgiguide with an ankylos configuration including the tubes for both systems.However, this is not possible with simplant.The second implant system was identified as a "3.0 fixation screw", which is not the same as the desired xive implant.In these cases, and to avoid any confusion, it is necessary to order two separate guides, one for each system to be used.The clinician stopped the surgery with just four implants (ankylos) placed.

• Brand Name: SURGIGUIDE GUIDE
• Type of Device: VARIOUS, EBG, LLZ, DZE
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt, limburg ; BE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4990627
• MDR Text Key: 22644332
• Report Number: 3007362683-2015-00016
• Device Sequence Number: 1
• Product Code: EBG
• 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: 05/28/2015

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: 37504
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• 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