FDA Adverse Event
Malfunction
Summary report: N
7.5MM REVOLVE POLYAXIAL PEDICLE SCREW, 45MM
MDR report key: 3964694
·
Received May 30, 2014
Report
- Report Number
- 3004142400-2014-00025
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- April 16, 2014
- Report Date
- April 22, 2014
- Manufacturer
- GLOBUS MEDICAL, INC.
- Product Code
- NKB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVAL, AND A THOROUGH REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED. SINCE NO REVISION HAS TAKEN PLACE AND SCREW REMAINS IN THE PT, NO FURTHER EVAL CAN BE PERFORMED. IF AND WHEN A REVISION SURGERY IS PERFORMED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED TO GLOBUS THAT PT HAS SUFFERED A BROKEN REVOLVE SCREW. NO REVISION SURGERY HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319999 | 7.5MM REVOLVE POLYAXIAL PEDICLE SCREW, 45MM | 7.5MM REVOLVE POLYAXIAL PEDICLE SCREW | NKB | GLOBUS MEDICAL, INC. | 185.475 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |