FDA Adverse Event
Malfunction
Summary report: N
POLARIS 6.35/SYNERGY SPINAL SYSTEM IMPLANTS AND INSTRUMENTS
MDR report key: 2230892
·
Received September 1, 2011
Report
- Report Number
- 2242816-2011-00107
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- April 20, 2011
- Report Date
- August 3, 2011
- Manufacturer
- EBI, LLC
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS 3 OF 3 MDRS ASSOCIATED WITH THIS EVENT. PLEASE ALSO SEE MDR NUMBERS: 2242816-2011-00105, 2242816-2011-00106.
Additional Manufacturer Narrative · 1
THIS IS 1 OF 3 MDRS ASSOCIATED WITH THIS EVENT. PLEASE ALSO SEE REPORT NUMBERS: 2242816-2011-00105 SUPP 1, 2242816-2011-00106 SUPP 1.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS IDENTIFIED THAT FOR TWO OF THE IMPLANTED SCREWS, THE SCREW HEADS BECAME DETACHED FROM THE SCREW SHAFT. THE TWO SCREWS WERE REMOVED AND REPLACED. 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 6.35/SYNERGY SPINAL SYSTEM IMPLANTS AND INSTRUMENTS | 6.5MMX35MM MULTI-AXIAL SCREW | KWQ | EBI, LLC | 87472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |