FDA Adverse Event
Injury
Summary report: N
XIA 3 TITANIUM RAD ROD DIAM 6MM L 40MM
MDR report key: 1884967
·
Received October 22, 2010
Report
- Report Number
- 9617544-2010-00428
- Event Type
- Injury
- Date Received
- October 22, 2010
- Date of Event
- August 24, 2010
- Report Date
- October 8, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- PMA / PMN Number
- K071373
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) AND SOMETIME BETWEEN THEN AND (B)(6)2010 THE PATIENT REPORTED A "POP" AND WAS IN SEVERE PAIN. X-RAYS WERE TAKEN ON (B)(6)2010 AND THE ROD APPEARS TO BE DISPLACED FROM THE TULIP HEAD OF THE SCREW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM RAD ROD DIAM 6MM L 40MM | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |