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

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

In this event it is reported that surgiguide; the guide splint clicked on very well, completely stable in place.The customer made a small mark on the bone crist top with the included pilot drill position 22.He thought the marking was a little too distal, but unfortunately chose to continue drilling the pilot drill to the bottom, it felt very distinct and good.Unfortunately, the direction turned out to be bad.The implant tipped so much distally that when he put on the healing abutment, it pressed so hard on tooth 23 that he couldn't even get a suture through.The customer had to pick up the fixture and sew again.The hole must now heal before they can re-operate (freehand this time).Additional information received: the customer removed the implant # 22 and did a fast bone augmentation.With implant # 12: no issues.

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Investigation: digital file review result: the registration of the model is done correctly, there is a small deviations on tooth 21, this was mentioned in the order remarks.It's a planning service order, the first planning proposal was not accepted.The customer changed the implant planning and this planning went to production.The design of the simplant guide is done correctly.The implants are completely surrounded by bone.Investigation: dhr result:this is a planning service order.The customer was informed for a lbv situation for implant positions 12 and 22.They requested to proceed as planned.In the order remarks the customer is informed about a small deviation in the registration on tooth 21 and implants 12 and 22 are planned close to the tooth roots of the neighboring teeth.The customer rejected the first design proposal.They made changes to the implant planning and uploaded their new plan.This plan was ok to proceed with and went to production.Investigation: return result: the fit of the guide on the model is good, the guide is finished correctly as well.The produced guide is the same as the designed guide.No issues found root cause: not determined.Conclusion code: no failure found.

• 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: 16452253
• MDR Text Key: 310335511
• Report Number: 3007362683-2023-00028
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 03/21/2023

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
• Device Lot Number: 8525258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/28/2023
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• Type of Device Usage: A
• Patient Sequence Number: 1