MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT 4.3 X 11.5 MM

Model Number 70-1154-IMP0011

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.When the device is returned an investigation will be carried out and a supplemental report will be submitted.Patient's weight is not recorded at the office.

Event Description

It was reported that a hahn tapered implant failed.The patient has bone type ii.There is no medical or dental history prior to implant.The patient presented on (b)(6) 2021 for primary procedure on tooth #29.During placement the cover screw broke in the patient's mouth.A failed attempt was made to remove parts of the cover screw.It was at that time the implant was removed.

Manufacturer Narrative

Additional information: section d d3: manufacturer address and phone number updated from initial submission.Section g g1:contacting office-manufacturing site address and phone number updated from initial submission.The device investigation has been completed and the results are as follows: dhr results: the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.The part met all the criteria called for in the production router.Stock product reviewed results: there was no stock product from lot# 6073391 available for review.Investigation methods/results: the device was returned with implant carrier but not in original packaging.The implant was verified to be a hahn tapered implant ø4.3 x 11.5 mm (70-1154-imp0011) using radiographic template (pk-209-062515).The body portion of the cover screw was still engaged in the implant.An attempt was made to retrieve the fractured portion of the cover screw but was unsuccessful.Root cause: a root cause for this complaint cannot be explicitly determined but most probably cause is improper seating of the cover screw or excessive torque.It is unclear if the appropriate prosthetic driver was used during placement.

• Brand Name: HAHN TAPERED IMPLANT 4.3 X 11.5 MM
• Type of Device: HAHN TAPERED IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; suite 250; irvine CA 92612
• MDR Report Key: 11860695
• MDR Text Key: 252398596
• Report Number: 3011649314-2021-00207
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• PMA/PMN Number: K143353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: 70-1154-IMP0011
• Device Catalogue Number: 70-1154-IMP0011
• Device Lot Number: 6073391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR