FDA Adverse Event
Other
Summary report: N
MALIBU POLYAXIAL SCREW
MDR report key: 1344072
·
Received March 11, 2009
Report
- Report Number
- 2032593-2009-00001
- Event Type
- Other
- Date Received
- March 11, 2009
- Date of Event
- March 3, 2009
- Report Date
- March 6, 2009
- Manufacturer
- SEASPINE, INC.
- Product Code
- MNI
- PMA / PMN Number
- K051942
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L LOT #: A1751B.
Description of Event or Problem · 1
INITIAL PRODUCT COMPLAINT WAS DATED 2008, PRODUCT WAS RETURNED 10-30-09. PRODUCT WAS RETURNED FOR EVALUATION BECAUSE THE MALIBU POLYAXIAL SCREWS APPEARED TO HAVE RUST NEAR THE HEAD. AT THIS TIME, IT WAS DETERMINED THAT THE RUST LIKE SUBSTANCE WAS LIKELY STAINING FROM A DIFFERENT SOURCE. INFORMATION RECEIVED 3-3-09 DETERMINED THAT INCORRECT MATERIAL WAS USED IN THE MANUFACTURE OF A COMPONENT OF THIS PRODUCT. THESE SCREWS WERE NOT INVOLVED WITH ANY PATIENTS OR SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALIBU POLYAXIAL SCREW | 888.3070 PEDICLE SCREW SPINAL SYSTEM | MNI | SEASPINE, INC. | NA | A1722A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |