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

Catalog Number 37503

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Sedation (2368)

Event Type  Injury  

Event Description

According to the available info, a doctor reported that a simplant surgiguide was used for placing three implants.The dentist realized intra-operatively that the tubes were too small for the intended drills.The dentist decided to postpone the surgical treatment and ordered a new guide.

Manufacturer Narrative

Investigation revealed that the wrong tubes were glued into the guide (sp=small platform instead of wp=wide platform).If this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.

• 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; susquehanna commerce ctr w., ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4448113
• MDR Text Key: 5393365
• Report Number: 3007362683-2014-00004
• 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: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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