STRAIGHT DRILL SCARLET AC-T
Report
- Report Number
- 3007728266-2024-00006
- Event Type
- Malfunction
- Date Received
- June 24, 2024
- Date of Event
- May 29, 2024
- Report Date
- July 30, 2024
- Manufacturer
- SPINEART SA
- Product Code
- ODP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
DESPITE OUR REQUESTS ON 31.MAY.2024, 04.JUN.2024, 07.JUN.2024, 04.JUL.2024, 09.JUL.2024 AND 12.JUL.2024, THE INSTRUMENT WAS NOT RETURNED, WE HAD NO INFORMATION ON THE BATCH NUMBER, NO INFORMATION ABOUT THE NEW SURGERY PLANNED ON (B)(6) 2024, NO OPERATIVE PICTURES. WE COULD NOT INVESTIGATE FURTHER/IDENTIFY ANY ROOT CAUSE.
FOR FURTHER INVESTIGATION WE ARE WAITING FOR THE RETURN OF THE INSTRUMENT, THE BATCH NUMBER IDENTIFICATION, INFORMATION ABOUT THE NEW SURGERY PLANNED ON (B)(6) 2024 AND OPERATIVE PICTURES (REQUEST ON (B)(6) 2024, (B)(6) 2024, (B)(6) 2024 AND (B)(6) 2024).
ON 31.MAY.2024, WE RECEIVED A COMPLAINT FROM SPAIN, REGISTERED UNDER (B)(4), REPORTING THAT DURING A SURGERY ON (B)(6) 2024, THE DRILL REFERENCE SCA-IC 09 00-N BROKE INSIDE THE VERTEBRAE OF THE PATIENT. THE PATIENT WAS FINE. A NEW SURGERY WAS PLANNED ON (B)(6) 2024. WE REPORT THIS CASE TO FDA BECAUSE THIS INSTRUMENT IS MARKETED ON THE US.
ON 31.MAY.2024, WE RECEIVED A COMPLAINT FROM SPAIN, REGISTERED UNDER (B)(4), REPORTING THAT DURING A SURGERY ON (B)(6) 2024, THE DRILL REFERENCE SCA-IC 09 00-N BROKE INSIDE THE VERTEBRAE OF THE PATIENT. THE PATIENT WAS FINE. A NEW SURGERY WAS PLANNED ON (B)(6) 2024. WE REPORT THIS CASE TO FDA BECAUSE THIS INSTRUMENT IS MARKETED ON THE US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2173746 | STRAIGHT DRILL SCARLET AC-T | STRAIGHT DRILL SCARLET AC-T | ODP | SPINEART SA | SCA-IC 09 00-N | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female |