SACROFUSE
Report
- Report Number
- 3005977257-2024-00001
- Event Type
- Malfunction
- Date Received
- March 28, 2024
- Date of Event
- February 26, 2024
- Report Date
- March 27, 2024
- Manufacturer
- LESSPINE INNOVATIONS
- Product Code
- LYP
- PMA / PMN Number
- K232605
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1541952 | SACROFUSE | IMPLANT INSERTER | LYP | LESSPINE INNOVATIONS | 14-42003 | DM05 | |
| 1985476 | SACROFUSE | IMPLANT INSERTER | LYP | LESSPINE INNOVATIONS | 14-42003 | DM05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |