MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. MGUIDE CASE, 2 SITE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number MG-STN2

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 09/07/2023

Event Type  Injury  

Event Description

The surgery took place on 7/9.There were 2 guides for this patient ( upper and lower jaw).The implant placement concerning the upper jaw was performed without a problem.For the lower jaw 2 implants ( positions # 36 and 46 ) had to be placed; implant 46 was placed without a problem.Dr.States that the sleeve # 36 got loose from the guide.What i understand is that the dr.Pushed the sleeve back in the guide and continued drilling with the unfortunate result that the drill fenestrated the lingual plate of the lower jaw.Hg, additional information received about the mguided surgery for position # 36: the customer performed the complete drilling protocol for the planned implant mis seven d4.2 l11.5 mm.It resulted in a complete fenestration of the lingual bone and the gingiva.The implant placement and bone grafting were not possible due to tearing of the entire lingual gum.A flap was made to close this site.No post op-images are available due to the state of the lingual gum.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.

Manufacturer Narrative

Investigation result: return the loose sleeve # 36 and the mguide returned for investigation.The support of the guide sleeve # 36 was broken at the distal and the mesial side, also a lingual part on the bottom of the sleeve support was broken off.The fit of the mguide on the printed model was ok.Digital file review: the digital mguide design meets specifications.Investigation attached.Dhr: no issues found.Failure mode: ( simplant) can not determine root cause root cause: customer misuse/abuse conclusion code: product failure - manufacturing.This is a follow up report for this additional information.

• Brand Name: MGUIDE CASE, 2 SITE
• 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: 17868690
• MDR Text Key: 324892615
• Report Number: 3007362683-2023-00039
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 12/07/2023

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: MG-STN2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/07/2023
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• Type of Device Usage: A
• Patient Sequence Number: 1