MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE GUIDE; VARIOUS

Catalog Number 37503

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Iatrogenic Source (2498)

Event Type  Injury  

Event Description

It was reported that a simplant guide was used for planning and placing three implants in the mandible.When preparing the implant site in region 45 (# 29) the drill hit the adjacent tooth (region 44/ #28).The doctor stated the longstop drill had too much space in the guide.

Manufacturer Narrative

The investigation of the returned guide and related accessories revealed no flaws in producing the guide, neither by using the wrong tubes nor presenting too high tolerances or an inaccurately manufactured guide.However, because a serious injury occurred, this event is reportable per 21 cfr part 803.

• Brand Name: SURGIGUIDE GUIDE
• Type of Device: VARIOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt limburg ; BE
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st., ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4702901
• MDR Text Key: 5644315
• Report Number: 3007362683-2015-00004
• 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
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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