MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH SURGIGUIDE; MULTIPLE, LLZ, DZE

Catalog Number 37503

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

In this event it was reported that an implant was removed after being placed too shallow.A surgiguide with implant depth control was used while placing the implant.

Manufacturer Narrative

Evaluation of the model shows the surgiguide was manufactured according to the specifications ordered by the doctor.However, because a serious injury occurred, this event is reportable per 21 cfr part 803.

• Brand Name: SURGIGUIDE
• Type of Device: MULTIPLE, LLZ, DZE
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; mannheim ; GM
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4118018
• MDR Text Key: 20783970
• Report Number: 9681851-2014-00008
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2014
• 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