MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. SURGIGUIDE - 2 IMPLANTS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Sinus Perforation (2277)

Event Date 10/09/2023

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 will be evaluated after receipt.Also production records will be investigated/evaluated.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.

Event Description

In this event it is reported that implant placed too deep in the sinus with use of surgiguide.The placement of implant #13/6 was successful, with the placement of implant #4/15, i did not find the implant and thought it had fallen in the mouth.An extra implant was placed successfully.Surgery was on (b)(6) 2023.After 3 months an opg was taken and the lost implant is unfortunately high in the sinus.I referred the patient to the stomatologist for removal of the implant, but this takes at least 3 months.The patient has no infection symptoms and no antibiotics were prescribed.The patient told me that he had a right eye infection, which can be linked, but is uncertain.Further information requested.

• Brand Name: SURGIGUIDE - 2 IMPLANTS
• 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: 17921002
• MDR Text Key: 325502362
• Report Number: 3007362683-2023-00042
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• 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: 10/12/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/09/2023
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 25232 ASTRATECH IMPLANT 4.2S L8.00 MM