MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. GLIDEWELL HT IMPLANT Ø4.3 X 8 MM; GLIDEWELL HT IMPLANT SYSTEM

Model Number	70-1189-IMP0009
Medical Device Problem Codes	Failure to Osseointegrate (1863); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, dr.(b)(6) reported that a 72-year-old female patient presented to his (b)(6) dental office with concerns related to a previously placed dental implant.The initial implant placement was performed on (b)(6) 2026 at tooth location #18.It was reported that the implant was placed after immediate extraction and was not immediately loaded.The patient presented with the issue on (b)(6) 2026, before the second-stage surgery.During the examination, the doctor discovered that the implant had failed to osseointegrate, and it was removed on the same day without the use of any instruments.The implant was not replaced.The patient was asymptomatic.The details of the prosthesis were a single tooth, and the opposing arch consisted of natural teeth.The patient did not sustain any permanent injury, and no additional medical or surgical procedures were required.It was further reported that the patient had type ii bone quality and good oral hygiene.No abnormalities with the implant or the package were reported.
Additional Manufacturer Narrative
The device was returned for analysis.However, the evaluation of the device is pending.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Once the investigation is completed, a supplemental report will be submitted.Manufacturer internal reference number: (b)(4).

• Brand Name: GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
• Common Device Name: GLIDEWELL HT IMPLANT SYSTEM
• 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: 24742472
• Report Number: 3011649314-2026-00486
• Device Sequence Number: 8695078
• Product Code: DZE
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70-1189-IMP0009
• Device Catalogue Number: 70-1189-IMP0009
• Device Lot Number: 6284013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female