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

Catalog Number 54500227

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

In this event it was reported that a simplant reduction guide fractured while the pt was under sedation.The guide was used intraoperatively to indicate the bone volume which needed to be reduced prior to implant placement.Due to lack of guidance the dentist decided to abort the surgical treatment and an additional unplanned procedure became necessary.

Manufacturer Narrative

According to the investigation, the reduction guide was too fragile to be useful for the resection of the bone due to the position of implants close to the foramen.To correct for this the procedure would have been for the clinician to either omit some implants from the guide or to reposition them slightly away from the foramen.Although the pt was not harmed the surgical intervention was not completed as intended due to malfunction of the product.As such, the event is reportable per 21 cfr part 803.

• Brand Name: REDUCTION GUIDE
• Type of Device: VARIOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt limburg ; BE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4380079
• MDR Text Key: 5289313
• Report Number: 3007362683-2014-00003
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54500227
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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