|
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
|
Patient Problems
Non-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2021 |
Event Type
Injury
|
Event Description
|
It was reported that on an unknown date, two locking screws backed out after the initial surgery.The implant was removed on (b)(6) 2021.It was replaced with a stryker nail.No further information provided.This report is for one (1) unk - nails: rfna.This is report 1 of 3 for (b)(4).
|
|
Manufacturer Narrative
|
This report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
The initial complaint was reviewed and found not reportable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|