MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Catalog Number 37503

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Because this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The initial planning has been investigated and the bone density at the implant sites 7,8 and 9 have been compared: the bone density is much lower for implant 9; the bone is much porous at this implant site.The implant 9 was placed deeper because the porous bone did not create enough of a counterpressure to indicate the end of the osteotomy has reached.

Event Description

It was reported that a surgiguide was used for preparation of three implants.The guide seated correctly and the drilling sequence was uneventful and identical for all three osteotomies.The implants were placed without the guide through a tissue punch.Post op x-ray revealed that one of the implants was 3 mm apical to planned location.The doctor was unable to retrieve the implant.

• Brand Name: SURGIGUIDE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer (Section G): DENTSPLY IMPLANTS N.V.; research campus 10; hasselt limburg, B-350 0; BE B-3500
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5157688
• MDR Text Key: 28552180
• Report Number: 3007362683-2015-00023
• Device Sequence Number: 1
• Product Code: LLZ
• 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
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• 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