FDA Adverse Event
Malfunction
Summary report: N
ROCCIA MULTILIF CAGE 9X34MM, 10 LOR.; ROCCIA MULTILIF CAGE 10X34MM, 10 LOR.
MDR report key: 17528661
·
Received August 12, 2023
Report
- Report Number
- MW5135591
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- March 12, 2020
- Manufacturer
- SILONY
- Product Code
- MAX
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE PATIENT REPORTS HAD TO UNDERGO 5 SPINAL FUSION SURGERIES. (FUSION FROM L4 TO S1).THE REASONS FOR THE NUMBER OF SURGERIES WERE MATERIAL FAILURES LIKE BROKEN SCREWS AND COMPLICATIONS WITH THE BONES GROWING AROUND THE SCREWS TO STABILIZE AND HEAL AS THE BONE MATERIAL DEGENERATED AROUND THE SCREWS THUS, MATERIAL INTOLERANCE IS SUSPECTED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2176100 | ROCCIA MULTILIF CAGE 9X34MM, 10 LOR.; ROCCIA MULTILIF CAGE 10X34MM, 10 LOR. | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | SILONY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |