FDA Adverse Event
Malfunction
Summary report: N
TIGER SPINE SYSTEM
MDR report key: 3060910
·
Received April 10, 2013
Report
- Report Number
- 1935627-2013-00011
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- October 17, 2012
- Report Date
- April 5, 2013
- Manufacturer
- CORELINK, LLC.
- Product Code
- MNH
- 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 ON (B)(6) 2012. DURING A POST-OPERATIVE EVALUATION ON (B)(6) 2012, THE RIGHT S1 PEDICLE SCREW WAS DETERMINED BY THE PHYSICIAN TO BE FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148516 | TIGER SPINE SYSTEM | PEDICLE SCREW SYSTEM | MNH | CORELINK, LLC. | 55075-50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |