MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. 30° MULTI-UNIT ABUTMENT, 3 MMH FOR CAMLOG SCREW-LINE 3.8 MM; INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS

Model Number 70-1135-CAM0143

Device Problem Break (1069)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis; however, the evaluation of the device is pending.At the completion of the investigation a supplemental report will be submitted with the analysis conclusion.Complaint history and product history records were reviewed; documentation indicated the product met release criteria.The probable or root cause of the event has not been identified.Manufacturer's internal reference number: (b)(4).

Event Description

A healthcare professional reported an inclusive multi-unit abutment with its screw fractured but the implant remained in place after the final prosthesis delivery on tooth 20.The prosthesis was removed with no observable clinical symptoms or permanent injury reported, the patient is doing well.At the time of the surgical procedure the patient's bone quality was type i with good oral hygiene status.It was reported that the patient has diabetes, bruxism, and dry mouth.

• Brand Name: 30° MULTI-UNIT ABUTMENT, 3 MMH FOR CAMLOG SCREW-LINE 3.8 MM
• Type of Device: INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2144 michelson drive; irvine CA 92612
• Manufacturer Contact: shelly gallup ; 2144 michelson drive; irvine, CA 92612 ; 9492223590
• MDR Report Key: 18976124
• MDR Text Key: 338767314
• Report Number: 3011649-2024-00176
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

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 Expiration Date: 08/05/2018
• Device Model Number: 70-1135-CAM0143
• Device Catalogue Number: 70-1135-CAM0143
• Device Lot Number: 6005175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White