FDA Adverse Event
Malfunction
Summary report: N
POLARIS 5.5 SYSTEM IMPLANTS
MDR report key: 2225840
·
Received August 29, 2011
Report
- Report Number
- 2242816-2011-00101
- Event Type
- Malfunction
- Date Received
- August 29, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 1, 2011
- Manufacturer
- EBI, LLC
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS 1 OF 4 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDRS: 2242816-2011-102, 2242816-2011-103, 2242816-2011-104.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN XRAY IDENTIFIED A FRACTURED SCREW. PHYSICIAN DECIDED TO LEAVE THE SCREW IMPLANTED AS THERE HAS BEEN NO ADVERSE EFFECT OR OTHER ISSUES ASSOCIATED WITH THE EVENT. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS 5.5 SYSTEM IMPLANTS | MULTIAXIAL SCREW | NKB | EBI, LLC | 641120, 8168391, 2189211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |