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 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been requested from the customer, but has not yet been received.An investigation is anticipated.Once the investigation is completed, a supplemental report will be submitted.The was no patient involvement.Expiration date: this device does not have an expiration date.Udi: udi information is not available.The device is not an implantable device.

Event Description

It was reported that an inclusive drill extender does not hold drills firmly.The doctor reported that drills fall off (out) of this drill extender easily with gravity.The doctor first noticed this issue on (b)(6) 2019.It was reported that there was no patient contact.The customer received the inclusive drill extender (sku 70-1071-srg0014, lot# 180827-007) as part of a hahn tapered implant surgical kit (sku 70-1071-srg0090, lot# 6062014).

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: the dhr from lot# 6062014 was reviewed and the receiving lot# 180827-007 passed all inspection, no product defect or non-conformity was reported.The certificate of conformance was provided by the supplier (integrity).Stock product results: there was no stock product from lot# 180827-007 available for review.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: 8677012
• MDR Text Key: 147317823
• Report Number: 3011649314-2019-00204
• 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

• Date FDA Received: 06/06/2019
• 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
• Device Lot Number: 180827-007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1