FDA Adverse Event
Malfunction
Summary report: N
INTERCONTINENTAL
MDR report key: 18812267
·
Received February 29, 2024
Report
- Report Number
- 3004142400-2018-00004
- Event Type
- Malfunction
- Date Received
- February 29, 2024
- Date of Event
- January 24, 2018
- Report Date
- February 29, 2024
- Manufacturer
- GLOBUS MEDICAL, INC.
- Product Code
- LXH
- PMA / PMN Number
- K103382
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. THE AVAILABLE PORTION OF THE INSTRUMENT WAS EVALUATED AND MEETS ALL MATERIAL SPECIFICATIONS. THE MANUFACTURING DOCUMENTATION FOR THE DRIVER TIP, WHICH REMAINS IN THE PATIENT, WAS REVIEWED AND FOUND COMPLIANT WITH ALL GLOBUS MEDICAL, INC. SPECIFICATIONS. USER ERROR MAY HAVE CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 0
DURING THE FINAL TIGHTENING OF THE SCREW, THE DRIVER TIP BROKE OFF AND COULD NOT BE REMOVED FROM THE SCREW HEAD. THE TIP REMAINS SEATED IN THE SCREW HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2002398 | INTERCONTINENTAL | 3.5MM ANGLED HEX DRIVER | LXH | GLOBUS MEDICAL, INC. | 687.504 | FAR007AD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Other |