MAUDE Adverse Event Report: DENTSPLY IH INC. SURGIGUIDE - 6 IMPLANTS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Positioning Failure (1158)

Patient Problem Laceration(s) (1946)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter.Product return is requested and product as well as the design planning will be evaluated.A follow-up report will be sent after the investigation is completed.Trend is tracked and monitored.

Event Description

Customer emailed on (b)(6) 2023 to let us know about a guide fit issue.Complaint was not entered by first agent.Followed up with customer today to get more details.When trying to seat the guide for surgery, the palatal portion was too high and the guide would not seat.Customer tried to seat the pilot guide that was initially ordered on accident (case (b)(4)) and it had the same issue.The customer tried to remove some resin from the palate to get it to seat, but realized that the guide did not match the patient's anatomy.The patient is a paraplegic and has difficulty getting to the office.The patient was not sedated.The patient was numbed, a small incision made, and then the customer stopped the procedure due to the guide not fitting.The customer will not proceed with surgery until the investigation is complete.

• Brand Name: SURGIGUIDE - 6 IMPLANTS
• 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: 17169422
• MDR Text Key: 317536247
• Report Number: 1222802-2023-00014
• 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
• Report Date: 06/21/2023

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: UNIQUE REFERENCE PER ORDER (CU
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/19/2023
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2022
• Type of Device Usage: A
• Patient Sequence Number: 1