Catalog Number HC455 |
Device Problems
Positioning Failure (1158); Connection Problem (2900)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Date of event unknown / not provided.
|
|
Event Description
|
It was reported that the abutment would not seat fully in the patient's mouth.
|
|
Manufacturer Narrative
|
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified some signs of use and but no apparent malfunction identified.Functional testing to recreate the reported event could be performed by using in-house compatible implant and the healing collar threaded as its intended.Device was located on tooth location #3 for approximately 1 month and 2 weeks.X-ray or picture image was not provided.A device history record review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported that the abutment would not seat fully in the patient's mouth.The reported complaint could not be confirmed.A definitive root cause for this complaint could not be determined.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.'.
|
|
Event Description
|
No further event information is available at the time of this report.
|
|
Search Alerts/Recalls
|