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

Catalog Number MG-STN3

Device Problems Break (1069); Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

The investigation results point out that the mguide was designed according to specifications based on the clinical data provided by the customer.Design was approved by customer.However some design deviations were noticed for implant position #35 (tube touching the bone in planning proposal; tube stick out with small surrounding resin designed), that in combination with possibly small amount of glue added during gluing operation could lead to tube loosening with applying lateral forces during the surgery.Ifu say that such forces need be be avoided.In this case, these lateral forces during surgery resulted in a crack in the resin of the mguide followed by the loosening of the cemented sleeve.From a clinical perspective patient harm in this case is very limited: injured tissue required recovery, that was performed by clinician immediately after event occurrence.New implant placement surgery will be planned after recovery with new mguide for position #35 only.This event is reportable per 21 cfr part 803.

Event Description

It was reported that sleeve # 35 came off a mguide during surgery drilling, which has led to injury of the patient as the drill deviates and intrudes lingually between the mandibular bone and soft tissue.

• Brand Name: MGUIDE
• 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 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12598935
• MDR Text Key: 275432324
• Report Number: 3007362683-2021-00007
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MG-STN3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/08/2021
• 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: N
• Patient Sequence Number: 1