FDA Adverse Event
Injury
Summary report: N
ONCONTROL COAXIAL TRAY(11/13GA X 102/147
MDR report key: 9111717
·
Received September 24, 2019
Report
- Report Number
- 3011137372-2019-00327
- Event Type
- Injury
- Date Received
- September 24, 2019
- Date of Event
- August 23, 2019
- Report Date
- August 29, 2019
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KNW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE TROCAR FIXED IN THE PELVIC BONE AFTER THE CEMENT WAS PLACED DURING THE SACROPLASTY. AFTER MULTIPLE ATTEMPTS TO REMOVE IT WITH THE HELP OF THE DRILL PROVIDED, THE DOCTOR TRIED TO TAKE IT WITH A UNIVERSAL CLIP. THE TROCAR THEN BROKE OFF AT THE BASE OF THE TROCAR AND IT NEEDED THE INTERVENTION OF AN ORTHOPEDIC SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907627 | ONCONTROL COAXIAL TRAY(11/13GA X 102/147 | KNW | TELEFLEX MEDICAL | 511630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |