FDA Adverse Event
Malfunction
Summary report: N
ELITE EXPANDABLE INTERBODY FUSION SYSTEM
MDR report key: 8672196
·
Received June 5, 2019
Report
- Report Number
- 2135156-2019-00003
- Event Type
- Malfunction
- Date Received
- June 5, 2019
- Date of Event
- May 9, 2019
- Report Date
- June 5, 2019
- Manufacturer
- SPINEOLOGY, INC.
- Product Code
- MAX
- UDI-DI
- M74054090010
- PMA / PMN Number
- K162879
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT UNDERWENT AN INTERBODY FUSION SURGERY WITH PLACEMENT OF AN ELITE EXPANDABLE DEVICE SUCCESSFULLY. AFTER INSTRUMENT PROCESSING, IT WAS NOTICED THAT THE IMPLANT INSERTER HAD A BROKEN TINE AND THE FRAGMENT COULD NOT BE LOCATED. IT IS UNKNOWN IF THIS FRAGMENT WAS RETAINED WITHIN THE PATIENT OR IF IT RESIDED ELSEWHERE. NO PATIENT CONSEQUENCE HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464426 | ELITE EXPANDABLE INTERBODY FUSION SYSTEM | INTERVERTEBRAL BODY FUSION DEVICE | MAX | SPINEOLOGY, INC. | ST18013 | M74054090010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |