FDA Adverse Event
Malfunction
Summary report: N
ALLY BONE SCREW-L
MDR report key: 8533796
·
Received April 19, 2019
Report
- Report Number
- 3009394448-2019-00003
- Event Type
- Malfunction
- Date Received
- April 19, 2019
- Date of Event
- March 26, 2019
- Report Date
- April 19, 2019
- Manufacturer
- PROVIDENCE MEDICAL TECHNOLOGY, INC.
- Product Code
- OVE
- PMA / PMN Number
- K163474
- Removal / Correction Number
- 3009394448-19-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING COMPLETION OF A 3 LEVEL ACDF, C3-C6, A SURGEON REPORTED MAL-POSITION OF THE INFERIOR ALLY BONE SCREW-L THROUGH A CAVUX CERVICAL CAGE-L IMPLANT AT C4-C5 LEVEL. THE SURGEON REMOVED BOTH SCREWS AND THE CAGE AND REPLACED THEM WITH ANOTHER CAGE AND 2 SCREWS, WHICH RESULTED IN MALPOSITION OF THE INFERIOR SCREW. THE SURGEON REPLACED DEVICES AGAIN AND ACHIEVED PROPER SCREW POSITION. THE OVERALL PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT ANY NEGATIVE CLINICAL SEQUALAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326839 | ALLY BONE SCREW-L | BONE SCREW | OVE | PROVIDENCE MEDICAL TECHNOLOGY, INC. | PD-32-602 | 045647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |