FDA Adverse Event
Injury
Summary report: N
SYNFIX LR 26MM DEPTH/32MM
MDR report key: 1030151
·
Received April 16, 2008
Report
- Report Number
- 1719045-2008-00043
- Event Type
- Injury
- Date Received
- April 16, 2008
- Report Date
- March 18, 2008
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- MAX
- PMA / PMN Number
- K072253
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IMPLANT CURRENTLY REMAINS IN PT. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
PT WITH GRADE 1-2 ISTHMIC SPONDYLOLISTHESIS UNDERWENT L5 TO S1 ALIF WITH SYNFIX. A FOLLOW UP X-RAY NOTED A SACRAL FRACTURE AND HARDWARE INTACT. SURGEON PERFORMED A PEDICAL SCREW REVISION. SYNFIX-LR REMAINS IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNFIX LR 26MM DEPTH/32MM | SYNFIX LR IMPLANTS | MAX | SYNTHES MONUMENT | NA | 2305188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention | SCREWS |