Catalog Number UNISG |
Device Problem
Fracture (1260)
|
Patient Problems
Inflammation (1932); Osteolysis (2377)
|
Event Date 10/19/2021 |
Event Type
Injury
|
Event Description
|
Doctor reported that 2 screws placed at tooth 36 and 37 fractured inside the implants and implants were removed.A portion of the screws remains inside the implants.
|
|
Manufacturer Narrative
|
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Additional device information unknown / not provided.Device manufacturer date unknown / not provided.
|
|
Manufacturer Narrative
|
Zimmer biomet complaint number (b)(4).Two full osseotite® tapered implant 4 x 11.5mm, fnt411 was returned for investigation.Visual inspection via naked eye and camera magnification was completed.Fractured screw fragments were identified in the implants.Implant damage identified from the removal process which may also have caused bone loss at the sites.Device history record (dhr) review could not be performed as the lot number associated with the unisg is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review for the unisg x 2 could not be performed as the lot/item numbers were unknown.Based on the available information, device malfunction did occur and the reported event was confirmed.
|
|
Event Description
|
No further event information is available at the time of the report.
|
|
Search Alerts/Recalls
|