FDA Adverse Event
Malfunction
Summary report: N
PATH FINDER
MDR report key: 961039
·
Received December 10, 2007
Report
- Report Number
- 1649384-2007-00957
- Event Type
- Malfunction
- Date Received
- December 10, 2007
- Report Date
- December 10, 2007
- Manufacturer
- ABBOTT SPINE, INC.
- Product Code
- MNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS NOT ASSOCIATED WITH A PT. THE DEVICE WAS NOT IMPLANTED. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUESTS HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.
Description of Event or Problem · 1
ON 12 NOV 2007 THE DISTRIBUTOR REPORTED THAT UPON RECEIVING THE SCREW IT WAS NOTED TO BE DISASSEMBLED. DATE OF EVENT IS UNK. THE EVENT WAS NOT ASSOCIATED WITH PT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATH FINDER | POLYAXIAL PEDICLE SCREW- 75MMX50 | MNI | ABBOTT SPINE, INC. | NA | 41YN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |