FDA Adverse Event
Injury
Summary report: N
ELITE EXPANDABLE INTERBODY FUSION DEVICE
MDR report key: 14085525
·
Received April 12, 2022
Report
- Report Number
- 2135156-2022-00003
- Event Type
- Injury
- Date Received
- April 12, 2022
- Date of Event
- March 14, 2022
- Report Date
- April 12, 2022
- Manufacturer
- SPINEOLOGY, INC
- Product Code
- MAX
- UDI-DI
- M74054100190
- PMA / PMN Number
- K162879
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT UNDERWENT AN INTERBODY FUSION WITH PLACEMENT OF AN ELITE EXPANDABLE DEVICE ON (B)(6) 2020 WITHOUT INCIDENT. IN (B)(6) 2021, THE PATIENT EXPERIENCED FAILED POSTERIOR CONSTRUCT RESULTING IN A REVISION SURGERY TO REPLACE BROKEN 3RD PARTY SCREWS. APPROXIMATELY SIX (6) MONTHS FOLLOWING THE REVISION SURGERY, THE PATIENT REPORTEDLY EXPERIENCED RETURN OF LOWER BACK PAIN PROMPTING ADDITIONAL MEDICAL ATTENTION. IMAGING SHOWED FRACTURE TO THE IMPLANT BOLT. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 VIA ALIF PROCEDURE TO REMOVE AND REPLACE THE IMPLANT. THE PATIENT IS NO LONGER EXPERIENCING ANY CLINICAL ISSUES OR COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145255 | ELITE EXPANDABLE INTERBODY FUSION DEVICE | INTERVERTEBRAL BODY FUSION DEVICE | MAX | SPINEOLOGY, INC | S90730 | M74054100190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention | 3RD PARTY POSTERIOR CONSTRUCT. |