UNKNOWN TRAUMA
Received Jun 22, 2016
Report 0001825034-2016-02201 · MDR key 5741594
Device
Product problems
- Difficult or Delayed Positioning
- Difficult or Delayed Positioning
Patient
Not reported
- Tissue Damage
- Tissue Damage
Narrative
Additional Manufacturer Narrative
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING MULTIPLE PROCEDURES, THE SURGEON HAD TO DRILL ADDITIONAL PILOT HOLES AS A RESULT OF THE PINS BEING DIFFICULT TO DEPLOY. IT IS UNKNOWN IF A DELAY OCCURRED DURING THE PROCEDURES.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT DURING MULTIPLE PROCEDURES, THE SURGEON HAD TO RE-DRILL PILOT HOLES AS A RESULT OF THE PINS BEING DIFFICULT TO DEPLOY. IT IS UNKNOWN IF A DELAY OCCURRED DURING THE PROCEDURES.