MalfunctionKGS
PRELOADED MINI-REVO ANCHR
Received Dec 11, 1998 · Event occurred Oct 16, 1998
Report 1017294-1998-00050 · MDR key 201934
Device
Product problems
- Break
- Difficult to Insert
- Device remains implanted
- Tip breakage
Patient
21 YR
- No Consequences Or Impact To Patient
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
DOCTOR PRE-DRILLED WITH A 2 MM DRILL. HE WAS ABLE TO SUCCESSFULLY PLACE ONE SCREW. WHEN ATTEMPTING TO INSERT THE REMAINING SCREWS, THREE OF THEM BROKE BETWEEN THE EYE AND THE THREAD OF THE SCREW. TWO OF THESE SCREWS WERE UNRETRIEVABLE.