FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 4151874
·
Received October 8, 2014
Report
- Report Number
- 1030489-2014-03918
- Event Type
- Injury
- Date Received
- October 8, 2014
- Report Date
- September 19, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLIF PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT A SCREW PULLED-OUT. IT IS UNKNOWN IF A REVISION WILL BE DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632411 | UNK | KWP | MEDTRONIC SOFAMOR DANEK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |