FDA Adverse Event
Malfunction
Summary report: N
C-TEK MAXAN IMPLANTS
MDR report key: 1638543
·
Received March 24, 2010
Report
- Report Number
- 2242816-2010-00046
- Event Type
- Malfunction
- Date Received
- March 24, 2010
- Date of Event
- October 8, 2009
- Report Date
- October 8, 2009
- Manufacturer
- EBI, LLC
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PART INVOLVED IN EVENT:PART NO. DESCRIPTION14-521614 14MMX4.0MM SCREW
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT WHILE INSERTING THE FIRST SCREW INTO THE PLATE, THE RING BEGAN TO TWIST. THE SCREW AND PLATE WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A SECOND PLATE AND SCREW. PATIENT OUTCOME: NO ADVERSE AFFECT REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-TEK MAXAN IMPLANTS | 1 LEVEL FIXED PLATE 12MM | KWQ | EBI, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |