MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 1 IMPLANT; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37501

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

The initial call was on (b)(6) 2023 the customer spoke with (b)(6) and explained to her that the guide had stability/fit issues when trying to use this guide.They did not proceed with the surgery.The initial call was disconnected.(b)(6) called the office back and left a voicemail, requesting somebody from the office to call back to get more details.Called doctor (b)(6) on 6/7 to about a different order when we finished.She asked what happened to order (b)(4).Then she explained what happened during the surgery.The doctor prepared for surgery extracted tooth and then proceeded to try in surgical guide.The doctor said it was rocking and there was space between the guide and teeth.So, she placed bone graft and didn't place implant.

Manufacturer Narrative

The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: SURGIGUIDE - 1 IMPLANT
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17133539
• MDR Text Key: 317205322
• Report Number: 3007362683-2023-00032
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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?: No
• Device Catalogue Number: 37501
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/07/2023
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention