Description of Event or Problem · 1
IT WAS REPORTED TO DEPUY ACROMED THAT A PT IN A CERVICAL HALO HAD SKULL PINS PENETRATE THE SKULL BONE. THE PT WAS IN AN ACCIDENT IN 1999. PT WAS PLACED IN A HALO AND THE HALO WAS REMOVED THREE MONTHS LATER. A YEAR LATER, THE PT COMPLAINED OF NECK PAIN AND IT WAS DISCOVERED THAT PROPER FUSION DID NOT OCCUR. THE PT WAS SURGICALLY INSTRUMENTED AS WELL AS PLACED IN ANOTHER HALO. SIX WEEKS LATER, THE PT COMPLAINED OF SEVERE PAIN AT THE PIN SITES. TWO PINS HAD PENETRATED THE SKULL. THE PINS WERE REMOVED AND NEW ONES WERE PLACED AT ADJACENT SITES. ONE WEEK LATER, A THIRD PIN HAD PENETRATED THE SKULL. AT THIS TIME THE HALO WAS REMOVED AND THE PATIENT WAS PLACED IN A CERVICAL THORACIC ORTHOSIS. ACCORDING TO THE SURGEON, THE PT HAS A HISTORY OF DRUG AND ALCOHOL ABUSE AND THE DR SUGGESTED THAT THE PT COULD HAVE BEEN MANIPULATING THEIR OWN PINS TO GAIN ACCESS TO PAIN MEDICATIONS. A COMPLAINT HISTORY ANALYSIS WAS PERFORMED AND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PART NUMBER. THE PARTS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE HOSPITAL. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AS THE PARTS WERE NOT RETURNED FOR EVAL. THERE HAVE BEEN NO OTHER COMPALAINTS REPORTED FOR THIS PART NUMBER, THE EVENT IS MOST LIKELY NOT DEVICE RELATED.