MalfunctionEPY
PAPAVERO-CASPAR SPEC SLIM-PROF 80X11MM
Received Jul 25, 2008 · Event occurred Jun 13, 2008
Report 2916714-2008-00017 · MDR key 1082143
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE OPENING SCREW STRIPPED WHILE IN THE PATIENT AND HAD TO BE CUT OUT WITH THE DRILL. NO PATIENT INJURY. SURGERY WAS DELAYED FOR TWENTY MINUTES.
Additional Manufacturer Narrative
DEVICE IS BEING HELD AT THE USER FACILITY AS PER THEIR POLICY. AESCULAP, INC HAS ATTEMPTED CONTACT WITH THE FACILITY IN ORDER TO FACILITATE RELEASE OF THE DEVICE FOR EVALUATION. ONCE RELEASED, ITEM WILL BE FORWARDED TO THE MANUFACTURING SITE FOR ANALYSIS.