FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 3012741
·
Received March 20, 2013
Report
- Report Number
- 1030489-2013-00790
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 19, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE HARDWARE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE AT L4-L5 VIA POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AND CORTICAL BONE TRAJECTORY TO TREAT SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE DURA SEEMED TO BE DAMAGED (POSSIBLE DUROTOMY). THE PROCEDURE WAS CONTINUED WITHOUT ANY FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116379 | UNKNOWN | KWP | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Other |