MAUDE Adverse Event Report: DENTSPLY IH INC. SIMPLANT GUIDE FILE DS DESIGN; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 37472

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that a patient experienced a dental implant loss.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Product return is requested and product will be evaluated after receipt.

• Brand Name: SIMPLANT GUIDE FILE DS DESIGN
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer (Section G): DENTSPLY IH INC.; 590 lincoln street; north waltham MA 02451
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17038993
• MDR Text Key: 316316102
• Report Number: 1222802-2023-00011
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/01/2023

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: 37472
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/23/2023
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 68011099 FOR POSITION # 29 LOT NUMBER 500344 ( PRI
• Patient Outcome(s): Required Intervention