FDA Adverse Event
Injury
Summary report: N
ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
MDR report key: 12888830
·
Received November 29, 2021
Report
- Report Number
- 3006340236-2021-00028
- Event Type
- Injury
- Date Received
- November 29, 2021
- Date of Event
- November 3, 2021
- Report Date
- November 30, 2021
- Manufacturer
- TITAN SPINE, INC.
- Product Code
- MAX
- UDI-DI
- 00763000202910
- PMA / PMN Number
- K201267
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OP DIAGNOSIS FOR MISTLIF THERAPY. IT WAS REPORTED THAT THE CAGE BACK OUT. PATIENT HAD LOWER BACK PAIN SINCE 15TH DAYS RADIATING TO LOWER LIMB. R>L. CT SCAN SHOWED DISPLACED FUSION DEVICE AT L5 S1 LEVEL CAUSING STENOSIS AFTER THE 1ST SURGERY. REVISION CASE DONE ON (B)(6) 2021. AND THE CAGE WAS EXPLANTED BY OPEN REVISION SURGERY. THE CAGE WAS REPLACED BY PATIENT AUTOGRAFT ONLY. NO CAGE WAS IMPLANTED AGAIN. AFTER THE REVISION SURGERY PATIENT IS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1779394 | ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, | MAX | TITAN SPINE, INC. | 84332412 | TM0128411 | 00763000202910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |