FDA Adverse Event
Malfunction
Summary report: N
TIGER SPINE SYSTEM
MDR report key: 3023043
·
Received March 21, 2013
Report
- Report Number
- 1935627-2013-00004
- Event Type
- Malfunction
- Date Received
- March 21, 2013
- Date of Event
- February 26, 2013
- Report Date
- March 15, 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
SALES REPRESENTATIVE RECEIVED NOTIFICATION FROM PHYSICIAN THAT DURING POST OPERATIVE EVALUATION THE PATIENT APPEARED TO HAVE EXPERIENCED BREAKAGE OF A SCREW. NO MANUFACTURER LOT NUMBER WAS ABLE TO BE OBTAINED. THEREFORE, A COMPLETE REVIEW OF THE PRODUCT WAS NOT POSSIBLE.
Description of Event or Problem · 1
PHYSICIAN REPORTED DURING POST-OPERATIVE EXAM THAT PEDICLE SCREW IMPLANTED DURING ON (B)(6) 2012 APPEARED TO BE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117759 | TIGER SPINE SYSTEM | PEDICLE SCREW SYSTEM | MNH | CORELINK, LLC | 55095-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |