MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT DRIVER Ø3.5/4.3 LONG

Model Number 70-1071-SRG0085

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

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.This complaint will be kept on record for track and trending purposes.

Event Description

It was reported that the hahn driver failed.The patient's bone type is listed as d1.The patient presented on an unknown date for a primary procedure on tooth #22.The provider noted when an attempt was made to place the healing cap over the implant it would not seat, at which point the provider realized the driver broke inside the implant.

Manufacturer Narrative

Additional information: section d: d1: brand name added.D2: common device name added.D4: model and catalog # added.Section g: g4: premarket/510(k) added.

Manufacturer Narrative

The device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results the lot information was not provided, the dhr could not be reviewed.Stock product reviewed results the lot information was not provided, the stock product could not be reviewed.Investigation methods/results customer did not return the device for investigation to date.Pictures provided by the customer was reviewed and the ring of the driver was detached from the driver.Root cause a root cause for this complaint cannot be explicitly determined.Probable root cause is improper seating of the implant driver into the internal hex of the implant.Additionally, it is unclear the methods of implant placement used during the initial procedure.Ifu 570 rev.3.0 (hahn tapered implant system) contained the following statement in the implant placement section: "step 2: initial placement - engage the implant connection with the appropriate driver.With the implant securely attached to the driver, squeeze the opposing end of the holder to disengage the implant from the holder.Transport the implant to the prepared site, and insert into the osteotomy.Rotate clockwise with applied pressure to engage the self-tapping grooves.Avoid lateral forces, which can affect the angulation and final alignment of the implant.Step 3: advancement and final seating - continue threading the implant into the osteotomy site using the preferred placement method.A minimum torque value of 35 ncm upon final seating indicates good primary stability." ifu 570 rev.3.0 (hahn tapered implant system) contained the following statement in the implant positioning section: "the implant should be rotated at the time of placement to ensure optimal positioning of the internal hex connection.This will allow the restoring clinician to take full advantage of the anatomical abutment contours and minimize the need for abutment preparation.Adjust the final position of the implant so that any one of the six flats of the internal hex connection is oriented toward the facial.".

• Brand Name: HAHN TAPERED IMPLANT DRIVER Ø3.5/4.3 LONG
• Type of Device: HAHN TAPERED IMPLANT DRIVER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: herbert crane ; 2144 michelson drive; irvine, CA 92612 ; 9495021907
• MDR Report Key: 16500094
• MDR Text Key: 310854754
• Report Number: 3011649314-2023-00125
• 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,Followup
• Report Date: 10/26/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1071-SRG0085
• Device Catalogue Number: 70-1071-SRG0085
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 03/07/2023; 10/06/2023
• Supplement Dates FDA Received: 03/14/2023; 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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