ACU-SINCH KNTLS MINI SYS W/INSRTR 2.3

Additional Manufacturer Narrative

TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION AND HAS BEEN REPORTED TO ACUMED THAT IT WILL NOT BE RETURNED, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT A 54 YEAR OLD PATIENT PRESENTED WITH SEVERE PAIN 6 MONTHS POST OP DUE TO ANCHOR BUTTON SUBSIDENCE. PER THE SURGEON'S PA: PAIN STARTED IN EARLY MARCH. PATIENT WAS IMMOBILIZED POSTOPERATIVELY UNTIL THE 6 WEEK MARK WITH WARM OCCUPATIONAL THERAPY WITH NO WEIGHTLIFTING. THERE WAS NO EVIDENCE OF NON-COMPLIANCE.