MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE DRILL EXTENDER

Model Number 70-1071-SRG0014

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received and the evaluation is anticipated.Once the investigation is completed, a supplemental report will be submitted.The was no patient involvement.There was no information available for the device's lot #.Therefore, no other device information is available.There was no information available for the device's lot #.Therefore, the device manufacture date is not available.

Event Description

It was reported that an inclusive drill extender does not hold drills firmly.The doctor reported that drills spin in the drill extender, and do not engage with the extender.The drill extender had been working fine until (b)(6) 2019.It was reported that there was no patient contact.The customer received the inclusive drill extender as part of a hahn tapered implant guided surgical kit.

Manufacturer Narrative

The device was returned, but did not transfer to the investigator.However, the device investigation has been completed and the results are as follows: device history results: unable to review the dhr or receiving router since the lot information was not provided (customer provided an invalid surgical kit lot number, hence the receiving lot number for drill extender cannot be found).Stock product results: unable to review the stock product since the lot information was not provided.Returned sample(s)/device results: customer returned the device for investigation.It was confirmed the device was lost during the transition due to the pandemic situation.Investigation results: since no device was available for investigation, there was no evidence found to indicate that the reported issue was caused by the device itself.Root cause: the root cause cannot be explicitly determined.The returned device was not inspected and measured against the specification.Conclusion summary: the complaint is unable to be evaluated.

• Brand Name: INCLUSIVE DRILL EXTENDER
• Type of Device: INCLUSIVE DRILL EXTENDER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine 92612
• MDR Report Key: 8761202
• MDR Text Key: 150400828
• Report Number: 3011649314-2019-00207
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

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: 70-1071-SRG0014
• Device Catalogue Number: 70-1071-SRG0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1