FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM BLOCKER
MDR report key: 3781006
·
Received April 30, 2014
Report
- Report Number
- 3005525032-2014-00064
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- March 27, 2014
- Report Date
- April 3, 2014
- Manufacturer
- STRYKER SPINE-SWITZERLAND
- Product Code
- MNH
- PMA / PMN Number
- K071373
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT MALFUNCTION RELATED TO THE REPORTED EVENT WAS FOUND WITH THIS PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THAT ANTERIOR XIA SURGERY WAS PERFORMED AND T11-L4 WAS FIXED. DURING A POST OPERATION FOLLOW UP IT WAS NOTICED THAT THE ROD BROKE AND THE REVISION SURGERY WAS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ANTERIOR XIA SURGERY WAS PERFORMED AND T11-L4 WAS FIXED. DURING A POST OPERATION FOLLOW UP IT WAS NOTICED THAT THE ROD BROKE AND THE REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259735 | XIA 3 TITANIUM BLOCKER | IMPLANT-BLOCKER | MNH | STRYKER SPINE-SWITZERLAND | PTY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |