MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCUSIVE SCREW COMPATIBLE WITH STRAUMANN; ABUTMENT

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Pain (1994)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

The dentist reported when torquing the screws to the bridge at 35ncm, the screws on the implant#7 and #9 fused to the implant head and broke.The screws were retrieved.However.The patient had to undergo a surgery to remove the implants.The patient is reported to be in satisfactory condition and no serious injury was reported.No information with regards to the lot number, patient information, or any additional information was provided by the practitioner.Also, the complaint part is yet to be returned for evaluation and investigation.A follow up report will be submitted after the completion of the investigation and evaluation.

Event Description

The doctor reported that a bridge was being delivered to the patient.When torquing the screws to the bridge at 35ncm, the screws on implant #7 and #9 fused to the implant head and broke.The broken screws were retrieved.The doctor tried to remove the screw on #6 crown and it also fused, the doctor did not want to remove the screws herself.The patient had to undergo a second surgery to remove the implants.

Manufacturer Narrative

Correction: section a a1: patient identifier updated as it was noted incorrectly on the supplemental.Section b b3: based on the information provided the date of event has been updated from the initial submission.B5: the description of the event has been revised from the intial submission.Additional information section a: a1:age at time of event, date of birth added.A3: patient sex added.A4: patient's weight added.Section e e1: initial reporter information added.This is the 1st of 3 failed implants reported on the same patient.Reference the following manufacturer reports for the remaining implants.3002195199-2017-00018 3011649314-2017-00569.

Event Description

It was reported that an inclusive screw failed on tooth #7.The patient presented on (b)(6) 2016 for primary procedure.On (b)(6) 2016 the patient returned for follow up procedure and the provider reported when torqueing the screw to the bridge the screws on implant fused to the implant head and broke.The broken screw was retrieved.

Manufacturer Narrative

Correction: section b b2: required intervention to prevent permanent impairment/damage (devices) select as it was omitted from the original submission.Section d d6a: implant date added as it was omitted from the initial submission.D6b: explant date added as it was omitted from the initial submission.Section h h1: updated from malfunction to serious injury based on the information provided.The device has not been returned.However, a nonvisual investigation has been completed and the results are as follows: device history record (dhr) review results: no lot number was provided.Stock product review results: complaint could not be verified returned sample(s)/device inspection results: no product was returned.Investigationresults: complaint could not be verified.Root cause: complaint could not be verified.

• Brand Name: INCUSIVE SCREW COMPATIBLE WITH STRAUMANN
• Type of Device: ABUTMENT
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 6341791
• MDR Text Key: 67927805
• Report Number: 3002195199-2017-00017
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K142118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR