FDA Adverse Event
Malfunction
Summary report: N
TIGER SPINE SYSTEM
MDR report key: 3060928
·
Received April 10, 2013
Report
- Report Number
- 1935627-2013-00014
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 4, 2013
- 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
THE EXPLANTED PARTS WERE NOT RETURNED FOR EVALUATION. 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) 2013 FOR A L4-L5 SURGERY. THE PATIENT HAD POST-OPERATIVE EVALUATIONS ON (B)(6) 2013. IT WAS DURING THE (B)(6) 2013 EVALUATION THAT THE PHYSICIAN INDICATED THAT THERE WAS BILATERAL L5 SCREW FRACTURES. THIS WAS DETERMINED THROUGH X-RAY IMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148495 | TIGER SPINE SYSTEM | PEDICLE SCREW SYSTEM | MNH | CORELINK, LLC. | 55075-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |