FDA Adverse Event
Injury
Summary report: N
INSERTER-LARGE
MDR report key: 2042160
·
Received March 28, 2011
Report
- Report Number
- 1719045-2011-00141
- Event Type
- Injury
- Date Received
- March 28, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
DURING A PRODISC-L PROCEDURE AT L4-L5, THE INSERTER DISENGAGED ABOUT HALF WAY IN. SURGEON REMOVED INSERTER FROM PATIENT, USED ANOTHER POLY AND RELOADED, AND IT POPPED OUT AGAIN. SURGEON THEN USED ANOTHER INSERTER, NEW POLY AND NEW INFERIOR PLATE. IMPLANT WAS PLACED AND PROCEDURE WAS COMPLETED. PROCEDURE WAS EXTENDED 45 MINUTES TO AN HOUR. AFTER COMPLETION OF THE PROCEDURE, IT WAS NOTED THE TIPS OF THE INSERTER WERE BENT. THIS IS REPORT #1 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSERTER-LARGE | INSERTER-LARGE | LXH | SYNTHES MONUMENT | NA | A7PA41 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | PRODISC-L IMPLANT |