Model Number HC455 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zimmer biomet complaint number (b)(4).
|
|
Event Description
|
It was reported that the implant was placed and the healing collar would not screw into implant.
|
|
Manufacturer Narrative
|
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified the first part of the threads were damaged.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing conditions were noted on the product experience report (per).The reported device was located on tooth # 14 (universal) and was not used.A device history record (dhr)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 related complaints for this product lot.Complainant reported that the implant was placed and the healing collar would not screw into the implant.The reported complaint could not be verified.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
|