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

Catalog Number 37502

Device Problems Defective Component (2292); Structural Problem (2506)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

A simplant surgiguide was used for planning and placing two implants.The customer reported that the length of the drills was incorrect and the tubes were fixed too deep leading to the drills going too deep into the bone.

Manufacturer Narrative

In addition he noted that the email for approval of changes was missing.The customer was contacted several times for add'l info, and we have not had a response.While it is believed that no serious injury resulted in this event, 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 reported per 21cfr part 803.Multiple unsuccessful attempts were made to obtain the device for eval.Multiple unsuccessful attempts were made to obtain the pt outcome.

• Brand Name: SURGIGUIDE GUIDE
• Type of Device: VARIOUS, EBG, LLZ, DZE
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt, lumburg ; BE
• Manufacturer Contact: helen lewis ; 221 w philadelphia st; susquehanna commerce ctr w., ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4448114
• MDR Text Key: 5386611
• Report Number: 3007362683-2014-00005
• 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: 09/16/2014

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: 37502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• 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