SACROFUSE
Received Mar 28, 2024 · Event occurred Feb 26, 2024
Report 3005977257-2024-00001 · MDR key 18997585
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THERE WERE TWO OTHER PAST COMPLAINTS ATTRIBUTED TO THE BROKEN TEETH OF THE INSERTER WHICH WERE REPORTED IN 2023 (3005977257-2023-00006 & 3005977257-2023-00009). A REVIEW OF LOT HISTORY SHOWS NO NON-CONFORMANCES OR DEVIATIONS ASSOCIATED, AND ALL DIMENSIONS ARE WITHIN THE SPECIFICATION. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. AN ACTIVE WORK RELATED TO ADDRESSING THE ROOT CAUSE IS ON-GOING TO COUNTER THE FAILURE OF IMPLANT INSERTER TEETH BREAK-OFF ISSUE WHEN USED FOR IMPLANT REMOVAL.
Description of Event or Problem
THE PATIENT SUFFERED SOME RESIDUAL PAIN DURING POST IMPLANTATION PERIOD AND IT WAS ASSESSED THAT SACRIX SCREW SITTING PROUD WAS THE POSSIBLE CAUSE OF THE PAIN. IN ORDER TO REMOVE THE IMPLANT, THE INSERTER (PRODUCT CODE LYP) WAS ATTACHED TO ONE OF THE IMPLANTS. WHILE TORQUING THE INSERTER TO REMOVE THE IMPLANT, THE CROWN DRIVE MECHANICAL PARTS WERE SHEARED OFF. THE SURGEON WAS ABLE TO SAFELY REMOVE ALL THE DEBRIS AND ABORTED THE PROCEDURE. PER THE ASSESSMENT FROM THE SURGEON THERE IS NO HARM TO THE PATIENT WAS OBSERVED.
Additional Manufacturer Narrative
THERE WERE TWO OTHER PAST COMPLAINTS ATTRIBUTED TO THE BROKEN TEETH OF THE INSERTER WHICH WERE REPORTED IN 2023 (3005977257-2023-00006 & 3005977257-2023-00009). A REVIEW OF LOT HISTORY SHOWS NO NON-CONFORMANCE'S OR DEVIATIONS ASSOCIATED, AND ALL DIMENSIONS ARE WITHIN THE SPECIFICATION. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. AN ACTIVE WORK RELATED TO ADDRESSING THE ROOT CAUSE IS ON-GOING TO COUNTER THE FAILURE OF IMPLANT INSERTER TEETH BREAK-OFF ISSUE WHEN USED FOR IMPLANT REMOVAL.
Description of Event or Problem
THE PATIENT SUFFERED SOME RESIDUAL PAIN DURING POST IMPLANTATION PERIOD AND IT WAS ASSESSED THAT SACRIX SCREW SITTING PROUD WAS THE POSSIBLE CAUSE OF THE PAIN. IN ORDER TO REMOVE THE IMPLANT, THE INSERTER (PRODUCT CODE LYP) WAS ATTACHED TO ONE OF THE IMPLANTS. WHILE TORQUING THE INSERTER TO REMOVE THE IMPLANT, THE CROWN DRIVE MECHANICAL PARTS WERE SHEARED OFF. THE SURGEON WAS ABLE TO SAFELY REMOVE ALL THE DEBRIS AND ABORTED THE PROCEDURE. PER THE ASSESSMENT FROM THE SURGEON THERE IS NO HARM TO THE PATIENT WAS OBSERVED.
Remedial action
- Patient Monitoring