MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. 30 MULTI-UNIT ABUT. 3 MMH COMPATIBLE WITH: CAMLOG SCREW-LINE 3.8 MM; 30° MULTI-UNIT ABUT. 3 MMH COMPATIBLE WITH: CAMLOG SCREW-LINE

Model Number 70-1135-CAM0143

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.The patients weight is not provided as it is not taken at the time of the appointment.The patients race/ethnicity was not provided when asked.Udi is not applicable for this device.

Event Description

The patient was presented on (b)(6) 2021 for primary implant placement on tooth location #4.The patient bone grade was noted as grade iv.The patient has a history hypertension and thyroid disease.It is reported that the "newly opened abutment.Cross threading of actual component." the provider further states that he "had to remove this abutment and open a new one that was not defective.The patient was having implant placement surgery.There was nothing wrong with the patient-just the defective component." the patient was not injured during the process.

Manufacturer Narrative

The device investigation has been completed and the results are as follows: dhr results: the dhr was reviewed and there was no evidence discovered to indicate that product defect or non-conformity observed from returned product.Stock product: the packaged stock product is not applicable for review since no defect was observed from the returned product.Investigation methods/results: device was returned but not original packaging.Device was determined to be a 30° multi-unit abut.3 mmh compatible with: camlog screw-line 3.8 mm using a diameter measured using a calibrated mitutoyo 0 - 1'' blade micrometer ( part no.422-330).Abutment screw was inspected and threading was found to be intact with no defects or deformities.Root cause: a root cause for this complaint cannot be explicitly determined.A probable cause can be incorrect insertion angle at the time of placement.

• Brand Name: 30 MULTI-UNIT ABUT. 3 MMH COMPATIBLE WITH: CAMLOG SCREW-LINE 3.8 MM
• Type of Device: 30° MULTI-UNIT ABUT. 3 MMH COMPATIBLE WITH: CAMLOG SCREW-LINE
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2301 dupont dr; suite 250; irvine CA 92612
• MDR Report Key: 11770269
• MDR Text Key: 248933671
• Report Number: 3011649314-2021-00173
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K121391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: 70-1135-CAM0143
• Device Catalogue Number: 70-1135-CAM0143
• Device Lot Number: 6018793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR