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

Catalog Number 37504

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

According to available information, a simplant surgiguide was used for planning and placing four (4) implants in the mandible of a patient.The preparation of the implant bed for 3 implants was successfully performed, while a fenestration of the lingual bone plate occurred when preparing the osteotomy for the implant in region 44.The investigation of the returned guide revealed that it was mirroring the situation as planned with the simplant software and provided the same position on the bone model as in the planning.The implant in region 44 was not placed and the surgical treatment was not completed as indicated.

Manufacturer Narrative

Therefore, because surgery could not be completed, this event is reportable per 21 cfr 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., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4585146
• MDR Text Key: 5447443
• Report Number: 3007362683-2015-00001
• 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: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• 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: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• 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