MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC.; HAHN SURGICAL GUIDE

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If/ when the device is returned an investigation will be carried out and a supplemental report will be submitted.Section d d1 and d4: complete device information not provided when asked.This complaint will be kept on record for track and trending purposes.

Event Description

It was reported that the hahn surgical guide failed.The patient's bone type is unknown.The patient has a removeable partial/full denture.The patient presented on (b)(6) 2023 for a primary procedure on tooth #11.The provider noted that the surgical guide, which was used to assist with implant placement may have been incorrect as implant placement was submerged below the bone level, and as a result, the implant span the implant was removed, and a new one was placed in a different location.

Manufacturer Narrative

The device was returned, the investigation has been completed and the results are as follows: dhr results: lot information not provided - dhr could not be reviewed.Stock product reviewed results: lot information not provided - stock product could not be reviewed.Investigation methods/results: customer did not return the reported device for review to date but returned an implant.However, the non-visual device investigation has been completed.Root cause: the root cause for this failure cannot be explicitly determined.Probable root cause is the over prepared osteotomy during the initial site preparation which may have caused the implant to submerge below the bone level.Additionally, it is unclear the methods of site preparation used during the initial procedure.Ifu 6538 rev 5.0 (hahn tapered implant guided surgery system) contains the following statement in site preparation section: "step 1: alignment drill - select the alignment drill with a diameter matching that of the implant.With copious irrigation, perforate the alveolar crest.Step 2: pilot drill (for ø3.5 mm - ø5.0 mm implants) - if placing a hahn tapered implant that is 3.5 mm in diameter or greater, pilot drills are used to deepen the osteotomy.Each pilot drill is labeled according to the diameter of implant for which it is intended to be used.Pilot drills are available in three lengths: a (8 mm), b (10 mm), c (13 mm).Select the appropriate pilot drill, accounting for the size of the implant to be placed, taking care not to exceed the length of the implant.If placing an implant that is 8 mm in length, pilot drill a should be used.If placing an implant that is 10 mm or 11.5 mm in length, pilot drill b should be used.If placing an implant that is 13 mm or 16 mm in length, pilot drill c should be used.With copious irrigation, drill a pilot hole to depth.Step 3: shaping drill - each shaping drill is both diameter- and length-specific, to match the size of the prescribed implant.Select the appropriate shaping drill, taking care not to exceed the length of the implant.With copious irrigation, drill to depth.The drill should correspond with the matching implant size, with the goal of achieving high primary stability upon implant placement.".

• Type of Device: HAHN SURGICAL GUIDE
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 16865780
• MDR Text Key: 314528616
• Report Number: 3011649314-2023-00251
• 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,Followup
• Report Date: 01/05/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: Black Or African American