ABC SELF-LOCKING CERVICAL SCREW
Received Jan 14, 2015 · Event occurred Dec 16, 2014
Report 3005673311-2015-00006 · MDR key 4436297
Device
Generic name
Cervical Screw
Manufacturer
Aesculap Ag And Co. KgModel number
FJ933TCatalog number
FJ933T
Lot number
51995724
Product problems
- Device Dislodged or Dislocated
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). SIX MONTHS LATER FROM THE FIRST SURGERY, ONE SCREW WAS BACK OUT. ON (B)(6) 2014 - FIRST SURGERY WAS CONDUCTED. ON (B)(6) 2014 - BY THE CT, THE SURGEON CONFIRMED THAT THE POSITION OF IMPLANT AND THE SITUATION OF PT ARE GOOD. AFTER THAT, THE CUSTOMER CHECKED OUT OF THE HOSPITAL AND HE WENT TO HOSPITAL REGULARLY. ON (B)(6) 2014 - BY THE CT, THE SURGEON FOUND THE SCREW WHICH PLACED IN C7 WAS BACK OUT. THEREFORE, REVISION SURGERY WOULD BE CONDUCTED ON (B)(6) 2014. ACCORDING TO THE OPINION OF SURGEON, THERE IS A POSSIBILITY THAT SCREW BEGAN TO COME AWAY ON (B)(6). IT WAS DIFFICULT TO CONFIRM THE BACK OUT, BECAUSE THE SCREW HAD BEEN PLACED IN C7.
Additional Manufacturer Narrative
MFG SITE EVAL: EVAL ON-GOING AT OEM.