MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT 3.5 X 11.5 MM

Model Number 70-1154-IMP0006

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

The patient's weight was not recorded by the doctor.The device has not been returned.When/if the device is returned for evaluation, the new information will be submitted in a supplemental report.

Event Description

It was reported that hahn a tapered implant failed.The implant was placed on (b)(6) 2020 at tooth location #4.The patient returned on (b)(6) 2020 with a portion of the broken implant in hand.The implant had the crown screwed in.The patient stated that the implant crown had felt loose for a few days, and then it came out.After examination, the doctor noted that the portion of the broken implant that the patient brought in was cracked about 3mm apical from the top.The remaining portion of the broken implant was still in the patient.It was at that time that the remaining portion of the implant was removed.The doctor stated "possible sinus perf/proximity during bone removal required for removing the implant".The doctor had to remove bone to remove the broken implant.The patient currently has the implant site grafted for future implant.The patient has a medical history of cholesterol condition, asthma, hypertension, anxiety, and diabetes.The patient has a dental history of numerous (5+) successful single tooth implant crowns.There were no abnormalities noted with the implant itself.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: investigation methods/results: the implant diameter and length were approximately measured along with a comparison against radiographic template (pk-209-062515).The implant was identified as a hahn tapered implant ø3.5 x 11.5 mm (70-1154-imp0010).The returned implant was broken just below the micro-threads and returned with the apex of the implant missing.The implant had defects and the threads were worn out.Bone debris was also observed on the implant.Practitioner provided an image of the missing portion which included crown still cemented to the top portion of the implant.Fracture point was visible in the image and confirmed to be just below the micro-threads of the device.Device history record review: 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 review: there was no stock product from lot# 6079507 available for review.Root cause: a root cause cannot be explicitly determined.It is unknown if the breakage was a result of poor prosthetic design.It is also unknown if the osteotomy size was undersized or over-prepared prior to the implant placement.

• Brand Name: HAHN TAPERED IMPLANT 3.5 X 11.5 MM
• Type of Device: HAHN TAPERED IMPLANT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine CA 92612
• MDR Report Key: 11155719
• MDR Text Key: 226524912
• Report Number: 3011649314-2020-00764
• 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: 06/16/2021

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-IMP0006
• Device Catalogue Number: 70-1154-IMP0006
• Device Lot Number: 6079507
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR