MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SIMPLANT SAFE GUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37502

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Only x-rays were provided, but not the guide.The x-rays show that the implants are placed too deep.However, the depth difference of 4mm as stated from the clinician cannot be confirmed as there is no post-op dicom data available.It is assumed, that seating the implants was done using the guide as stated by the clinician.On the planning provided by the customer, the shortest distance between the nerve and the implant position 20 is around 1.81 mm.As per digital findings simplant guide was manufactured according to spec.The design of the guide is fully made in accordance to the preoperative plan created and approved by the clinician.Because a serious injury resulted, this event is reportable per 21 cfr part 803.

Event Description

According to the available information, a patient received two implants (astra tech ev; two different lengths) on (b)(6) 2018 in region 19 and 20 (fdi # 35 and 36) by using a simplant safe guide - astra tech ev and the astra tech ev guided surgery kit.On x-ray after surgery the clinician noticed the implant positions were too deep.He elevated the implant at position 20 to the crestal bone and removed the implant at position 19 completely.Whether this was done right after surgery is unknown.After the surgery the patient complained of numbness.The clinician believes that the nerve was hit during one of the drilling steps.

• Brand Name: SIMPLANT SAFE GUIDE
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• 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: 7628058
• MDR Text Key: 111973240
• Report Number: 3007362683-2018-00004
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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
• Treatment: 2 ASTRA EV DENTAL IMPLANTS
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR