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 Type  malfunction  

Manufacturer Narrative

The device has not been returned.When/if the device is returned for evaluation, the new information will be submitted in a supplemental report.The doctor could not provide the date of event.(lot#, expiration date, udi): no information available since customer could not provide a lot number.The device has not been explanted.No information available since customer could not provide a lot number.

Event Description

It was reported that a hahn tapered implant failed.The implant was placed on (b)(6) 2017 at tooth location #29.The patient returned later at an unknown date with a broken (fractured) portion of the implant in hand.The broken portion of the implant had the restoration screwed onto it.The remaining portion of the implant was still in the patient.The patient declined to have the remaining portion of the implant removed, and has not returned to have it removed.The patient was last reported to be in stable condition with the broken portion of the implant still in place.The patient has type d2 bone quality, and has no relevant medical or dental history.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: investigation methods/results: customer returned what appears to be the crest portion of the implant, identifiable by the micro-threading and color coated internal hex.Type, model, or size of the implant could not be verified but appears to be a portion from the hahn tapered implant family.Remaining body of the implant was not removed and is still in the patient.Device history record review: lot number was not provided - dhr could not be reviewed.Stock product review: lot number was not provided - stock product could not be reviewed.Root cause: the root cause was inconclusive and cannot be explicitly determined.Customer did not report any osseointegration issue or any abnormality with the implant.The probable cause for the fracture could be contributed by patient factors.

• 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: 11283202
• MDR Text Key: 233045580
• Report Number: 3011649314-2021-00022
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1154-IMP0006
• Device Catalogue Number: 70-1154-IMP0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 95