FDA Adverse Event
Malfunction
Summary report: N
TIGER SPINE SYSTEM
MDR report key: 3060909
·
Received April 10, 2013
Report
- Report Number
- 1935627-2013-00010
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- November 2, 2012
- Report Date
- April 5, 2013
- Manufacturer
- CORELINK, LLC.
- Product Code
- HWC
- PMA / PMN Number
- K110321
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
TIGER SPINE SYSTEM PEDICLE SCREWS WERE IMPLANTED IN PATIENT ON (B)(6) 2012. THE PATIENT HAD POST-OP EVALUATIONS ON (B)(6) 2012. IT WAS NOT UNTIL THE POST-OP EVALUATION ON (B)(6) 2012 THAT THE PHYSICIAN DISCOVERED THE RIGHT S1 PEDICLE SCREW TO BE FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153650 | TIGER SPINE SYSTEM | PEDICLE SCREW SYSTEM | HWC | CORELINK, LLC. | 55065-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |