GLIDEWELL HT IMPLANT Ø3.5 X 10 MM (PRISMATIK DENTALCRAFT, INC.) — Injury
An injury event was reported involving a Glidewell HT Implant (Ø3.5 x 10 mm). The manufacturer, Prismatik Dentalcraft, Inc., reported that the device was not returned for analysis, precluding a definitive investigation at this time.
The manufacturer (Prismatik Dentalcraft, Inc.), post-market surveillance teams, and clinicians utilizing Glidewell HT dental implants.
The inability to perform a physical analysis of the device limits the manufacturer's capacity to identify potential manufacturing defects or clinical complications. This report underscores the importance of the supplemental reporting process, as the manufacturer has committed to providing further analysis should the device be returned. Regulatory professionals should note the ongoing nature of this investigation.
QA and complaint handling teams should ensure that all efforts to retrieve explanted or failed devices are documented to support thorough root cause investigations. If the device remains unavailable, documentation must justify why a full analysis could not be performed at the time of the initial report.
Event type: Injury. Device: GLIDEWELL HT IMPLANT Ø3.5 X 10 MM by PRISMATIK DENTALCRAFT, INC.. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. MANUFACTURER REFERENCE: (B)(4).
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